Effectiveness of Sugammadex in LMS Surgery

• Sponsor: Korea University Anam Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02329964
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Duration (Months): 19

Study Details

Study Description

Brief Summary

This study is comparing of rocuronium-sugammadex and succinylcholine during LMS surgery that is characterized by short operation time, required intense paralysis and ambulatory setting, has not been investigated.

Condition or Disease	Intervention/Treatment	Phase
Muscle Relaxation	Drug: Sugammadex; Drug: Neostigmine	Phase 4

Detailed Description

Laser microlaryngeal surgery (LMS) requires brief and intense paralysis in the short operation time and the ambulatory setting.

The ideal muscle relaxant with rapid onset time, short duration of action and minimal side effects is not yet available.

Succinylcholine (SCC) is commonly used muscle relaxant for LMS because of its rapid onset time and short duration of action.

The use of SCC for tracheal intubation is usually followed by repeated small boluses or drip of SCC or small boluses of nondepolarizing muscle relaxants with intermediate duration.

As an alternative to SCC, the non-depolarizing neuromuscular blocking agent rocuronium can be used for LMS. The onset of rocuronium 1mg/kg is around 60s that is similar to SCC. However higher doses of rocuronium have a long duration of action; this is inappropriate in ambulatory surgery that requires rapid recovery of neuromuscular function and rapid turnover.

Sugammadex has recently been introduced as a selective relaxant-binding agent that allows for rapid reversal of rocuronium-induced neuromuscular blockade. Even profound neuromuscular block with rocuronium can be quickly antagonized with sugammadex.

After obtaining Institutional Review Board approval and written informed consent, 80 patients is enrolling in this study.

Patients is divided by two groups randomly as the Rocuronium-Sugammadex group(R-S group) and the Succinylcholine - Cisatracurium- Neostigmine group(S-C-N group) .

Anesthesia was induced with intravenous propofol 1.5-2.5 mg/kg, together with fentanyl1.5 mcg/kg After induction of anesthesia, neuromuscular monitoring is performed continuously at the adductor pollicis muscle with acceleromyography (TOF-Watch®).

Subsequently, in the R-S group, patients receive rocuronium 1mg/kg and in the S-C-N group, patients receive SCC 1mg/kg.

After T1 assessed as being zero by neuromuscular monitoring, endotracheal intubation is performed.

After endotracheal intubation, in the S-C-N group, cisatracurium 0.08mg/kg is injected and in the R-S group, the same volume of normal saline is injected.

Anesthesia is maintained with desflurane with air during the surgery. Additive dose of rocuronium 0.15mg/kg or SCC 10mg is given as necessary to ensure that neuromuscular blockade remains below T2 during surgery.

After the surgical procedure ends, patients receive sugammadex 2mg/kg in the R-S group, and pyridostigmine 0.2 mg/kg with atropine 10mcg/kg in the S-C-N group at the appearance of second TOF twitch (T2).

Patient will be assessed for the time to recovery of the TOF ratio to 0.9, surgical rating scale (1- extremely poor conditions, 2- poor conditions, 3- acceptable conditions, 4- good conditions, 5- optimal conditions), and anesthesia time.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Comparison of the Effectiveness of Rocuronium - Sugammadex With Succinylcholine-Cisatracurium-Neostigmine in Patients Undergoing Laser Microlaryngeal Surgery
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Anticipated Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R-S group Rocuronium-Sugammadex group Induction of anesthesia : 1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg Muscle relaxant agent : Rocuronium 1mg/kg After endotracheal intubation : normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery : sugammadex 2mg/kg	Drug: Sugammadex; Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.; Other Names: Bridion
Active Comparator: S-C-N group Succinylcholine-Cisatracurium-Neostigmine group Induction of anesthesia :1% propofol 1.5-2.5 mg/kg with fentanyl 1.5 mcg/kg Muscle relaxant agent :Succinylcholine 1mg/kg After endotracheal intubation : Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery : Succinylcholine 10mg Relaxant agent reversal at the appearance of second TOF twitch (T2) : Neostigmine 0.2mg/kg with atropine 10 mcg/kg (for preventing side effects of neostigmine)	Drug: Neostigmine; Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.; Other Names: Pyridostigmine(Pyrinol)

Outcome Measures

Primary Outcome Measures

1. Recovery of T1 to 90% [from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes]

   we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.

2. Surgical Rating Score [during surgery]

   describe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions

3. Addition of Neuromuscular Blocking Agents [during surgery]

   Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed. In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery. We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery

4. Recovery of T1 to 10% [from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes]

   we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.

Secondary Outcome Measures

1. Time to Extubation [from the end of surgery to extubate a tracheal tube]

   We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation

2. Time to First Spontaneous Breath [from end of surgery to first spontaneous breaths]

   time from end of surgery to first spontaneous breaths

3. Time to Eye Opening [from end of surgery to opening of the eyes to verbal commands]

   We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.

Other Outcome Measures

1. Length of Stay in te Operating Room [time from in to out of the operating room]

   LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.

2. Anesthesia Time [from the anesthesia start to end]

   time from propofol injection to extubation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• American Society of Anesthesiologist[ASA] class 1-3

• scheduled Laser microlaryngeal surgery under general anesthesia

• written informed consent

Exclusion Criteria:

• suspected difficult tracheal intubation

• disorder affecting neuromuscular blockade

• known or suspected significant renal dysfunction

• known or suspected severe hepatic dysfunction

• history of malignant hyperthermia

• allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia

• contraindication to pyridostigmine and/or atropine

• pregnancy

• breast feeding

• body mass index > 27kg/m2

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Korea University Anam Hospital

Investigators

• Principal Investigator: Jangeun Cho, M.D.,Ph.D., Anesthesia and pain medicine department, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seol Ju, Park, Resident, Korea University Anam Hospital
• ClinicalTrials.gov Identifier: NCT02329964
• Other Study ID Numbers: LMS-sugammadex study KoreaUH
• First Posted: Jan 1, 2015
• Last Update Posted: Sep 28, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Seol Ju, Park, Resident, Korea University Anam Hospital: Rocuronium; Sugammadex; Succinylcholine; Cisatracurium; Neostigmine; acceleromyography (TOF-Watch®)
• Additional relevant MeSH terms: Neostigmine; Pyridostigmine Bromide

Study Results

Participant Flow

Recruitment Details	Recruitment period : 2015.2.10 - 2015.6.30 Location : Korea University Medical Center Anam Hospital

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	R-S Group	S-C-N Group	Total
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)	Total of all reporting groups
Overall Participants	40	40	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	37 92.5%	32 80%	69 86.3%
>=65 years	3 7.5%	8 20%	11 13.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (12)	52 (15)	50 (13)
Sex: Female, Male (Count of Participants)
Female	18 45%	16 40%	34 42.5%
Male	22 55%	24 60%	46 57.5%

Outcome Measures

1. Primary Outcome

Title	Recovery of T1 to 90%
Description	we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
Time Frame	from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Median (Inter-Quartile Range) [seconds]	377	240

2. Primary Outcome

Title	Surgical Rating Score
Description	describe by surgeon under his subjective opinion. 1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Median (Inter-Quartile Range) [score]	5.0	5.0

3. Primary Outcome

Title	Addition of Neuromuscular Blocking Agents
Description	Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed. In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery. We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery
Time Frame	during surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Number [participants]	0 0%	20 50%

4. Secondary Outcome

Title	Time to Extubation
Description	We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation
Time Frame	from the end of surgery to extubate a tracheal tube

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Median (Inter-Quartile Range) [seconds]	430	380

5. Other Pre-specified Outcome

Title	Length of Stay in te Operating Room
Description	LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.
Time Frame	time from in to out of the operating room

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Mean (Standard Deviation) [minutes]	31.0 (7.7)	38.6 (7.5)

6. Other Pre-specified Outcome

Title	Anesthesia Time
Description	time from propofol injection to extubation
Time Frame	from the anesthesia start to end

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Mean (Standard Deviation) [minutes]	28.4 (7.5)	35.2 (7.0)

7. Primary Outcome

Title	Recovery of T1 to 10%
Description	we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.
Time Frame	from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Median (Inter-Quartile Range) [seconds]	271	190

8. Secondary Outcome

Title	Time to First Spontaneous Breath
Description	time from end of surgery to first spontaneous breaths
Time Frame	from end of surgery to first spontaneous breaths

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Median (Inter-Quartile Range) [seconds]	263	240

9. Secondary Outcome

Title	Time to Eye Opening
Description	We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.
Time Frame	from end of surgery to opening of the eyes to verbal commands

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	R-S Group	S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg	Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
Measure Participants	40	40
Median (Inter-Quartile Range) [seconds]	340	300

Adverse Events

Arm/Group Title	R-S Group		S-C-N Group
Arm/Group Description	Rocuronium-Sugammadex group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Rocuronium 1mg/kg After endotracheal intubation normal saline(0.025 ml/kg) Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Rocuronium 0.15mg/kg Relaxant agent reversal. at the the end of surgery. sugammadex 2mg/kg		Succinylcholine-Cisatracurium-Neostigmine group Induction agent : IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg During induction of anesthesia, as muscle relaxant agent Succinylcholine 1mg/kg After endotracheal intubation, Cisatracurium 0.08mg/kg Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery Succinylcholine 10mg Relaxant agent reversal. at the appearance of second TOF twitch (T2). Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)
All Cause Mortality
	R-S Group		S-C-N Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	R-S Group		S-C-N Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	R-S Group		S-C-N Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

The surgical rating score was assessed on the basis of the degree of laryngx exposure. This was influenced not only by neuromuscular relaxation but also by anatomical factors.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.