The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02109133
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Robot-Assisted Laparoscopic Radical Prostatectomy	Procedure: deep neuromuscular blockade; Procedure: moderate neuromuscular blockade; Drug: Rocuronium; Drug: Sugammadex; Drug: Atracurium; Drug: Neostigmine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deep neuromuscular blockade Deep neuromuscular blockade	Procedure: deep neuromuscular blockade; deep neuromuscular blockade using rocuronium and reverse with sugammadex; Drug: Rocuronium; Drug: Sugammadex
Active Comparator: moderate neuromuscular blockade moderate neuromuscular blockade	Procedure: moderate neuromuscular blockade; moderate neuromuscular blockade using atracurium and reverse with neostigmine; Drug: Atracurium; Drug: Neostigmine

Outcome Measures

Primary Outcome Measures

1. Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade [Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position]

   maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade

Secondary Outcome Measures

1. Overall Surgical Condition [At the end of the Steep trendelenburg position, an average of 1 hour]

   overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.

Other Outcome Measures

1. Post-operative Nausea [During 24hours after operation]

2. Incidence of Residual Neuromuscular Blockade [During 24hours after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. ASA class I-II

2. obtaining written informed consent from the parents

3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy

Exclusion Criteria:

1. eye surgery previously

2. unstable angina or congestive heart failure

3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)

4. high intraocular pressure over 30mmHg after screening test.

5. uncontrolled hypertension (diastolic bp>110mmHg)

6. coagulopathy

7. asthma

8. hepatic failure

9. renal failure(creatinine clearance < 30 ml/min)

10. drug hyperactivity

11. neurological or psychiatric illnesses

12. mental retardation

13. patients who can't read the consent form due to illiterate or foreigner

14. previous malignant hyperthermia Hx

15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)

16. BMI > 30kg/m2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02109133
• Other Study ID Numbers: 4-2014-0058
• First Posted: Apr 9, 2014
• Last Update Posted: Jun 24, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Yonsei University: deep neuromuscular blockade; intraocular pressure
• Additional relevant MeSH terms: Rocuronium; Atracurium; Neostigmine

Study Results

Participant Flow

Recruitment Details	Subjects were screened and enrolled at 1 site in the Korea
Pre-assignment Detail	No test entered

Arm/Group Title	Moderate Neuromuscular Blockade (Moderate NMB Group)	Deep Neuromuscular Blockade (Deep NMB Group)
Arm/Group Description	Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.	Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
Period Title: Overall Study
STARTED	33	34
COMPLETED	32	34
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Moderate Neuromuscular Blockade	Deep Neuromuscular Blockade	Total
Arm/Group Description	moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine Atracurium Neostigmine	deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex Rocuronium Sugammadex	Total of all reporting groups
Overall Participants	32	34	66
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 50%	22 64.7%	38 57.6%
>=65 years	16 50%	12 35.3%	28 42.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (6.1)	61.5 (5.4)	62.7 (5.7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	32 100%	34 100%	66 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	32 100%	34 100%	66 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Korea, Republic of	32 100%	34 100%	66 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
Description	maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade
Time Frame	Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moderate Neuromuscular Blockade (Moderate NMB Group)	Deep Neuromuscular Blockade (Deep NMB Group)
Arm/Group Description	Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.	Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
Measure Participants	32	34
Mean (Standard Deviation) [mmHg]	23.3 (2.7)	19.8 (2.1)

2. Secondary Outcome

Title	Overall Surgical Condition
Description	overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.
Time Frame	At the end of the Steep trendelenburg position, an average of 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moderate Neuromuscular Blockade	Deep Neuromuscular Blockade
Arm/Group Description	moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine Atracurium Neostigmine	deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex Rocuronium Sugammadex
Measure Participants	32	34
Median (Inter-Quartile Range) [units on a scale]	4.0	3.0

3. Other Pre-specified Outcome

Title	Post-operative Nausea
Time Frame	During 24hours after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moderate Neuromuscular Blockade (Moderate NMB Group)	Deep Neuromuscular Blockade (Deep NMB Group)
Arm/Group Description	Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.	Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
Measure Participants	32	34
Number [events]	4	1

4. Other Pre-specified Outcome

Title	Incidence of Residual Neuromuscular Blockade
Time Frame	During 24hours after operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Moderate Neuromuscular Blockade (Moderate NMB Group)	Deep Neuromuscular Blockade (Deep NMB Group)
Arm/Group Description	Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.	Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
Measure Participants	32	34
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Moderate Neuromuscular Blockade		Deep Neuromuscular Blockade
Arm/Group Description	moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine Atracurium Neostigmine		deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex Rocuronium Sugammadex
All Cause Mortality
	Moderate Neuromuscular Blockade		Deep Neuromuscular Blockade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Moderate Neuromuscular Blockade		Deep Neuromuscular Blockade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Moderate Neuromuscular Blockade		Deep Neuromuscular Blockade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.