Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02174913
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 21.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS can reduce total propofol dose when being used with target controlled infusion (TCI).The objective is to compare awakening time after spine surgery between using clinical signs and bispectral index (BIS) guided target controlled infusion(TCI) of propofol in patients having neurophysiologic monitoring.

Condition or Disease	Intervention/Treatment	Phase
Spine Diseases	Device: bispectral index; Drug: Target controlled infusion of propofol; Drug: Fentanyl; Drug: Atracurium	N/A

Detailed Description

34 patients undergoing spine surgery will be enrolled and randomly assigned into two groups. We exclude patients who age under 18 and over 80 years, preoperative hemodynamics instability, propofol allergy, receiving drugs interfered with EEG, liver disease, Body Mass Index (BMI) over 30 kg/m2. Before induction the patient will be given 0.9% Sodium Chloride (NaCl) or acetate Ringer solution 7 ml/kg. Standard monitorings are used to all patients.

Control group will receive fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol TCI target 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. The TCI propofol will be adjusted by clinical monitoring. If the patient has minor movement, the propofol TCI will be increased incrementally to 0.5 mcg/ml higher level but if major movement occurs the dose will be increased to1.0 mcg/ml higher. When hypotension occurs, this will be treated by fluid loading 200 ml in 10 min if it is not improved, then ephedrine or norepinephrine will be given and the TCI dose will be decreased by 0.5 mcg/ml lower level but not lower than 3.0 mcg/ml. Hypertension will be treated by fentanyl bolus 0.5 mcg/kg and increasing TCI dose to 0.5 mcg/ml higher level but not more than 7 mcg/ml. If hypertension persist, the nicardipine or diltiazem will be given.

Intervention group receives fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol by TCI 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. Propofol will be adjusted by BIS monitoring. If the movement occurs and BIS 40-60, fentanyl 0.5 mcg/kg will be given, BIS > 60, TCI dose will be increased 0.5 mcg/ml higher level until BIS 40-60. When hypotension occurs, if BIS 40-60, will be treated by load fluid 200 ml in 10 mins, then ephedrine or norepinephrine will be given, If BIS < 40 the TCI dose will decrease 0.5 mcg/ml but not lower than 3.0 mcg/ml. Hypertension occurs, if BIS > 60 will be treated by fentanyl bolus 0.5 mcg/kg and TCI dose will be increased 0.5 mcg/ml higher level but not more than 7 mcg/ml if not improved, nicardipine or diltiazem will be given. if BIS 40-60, nicardipine or diltiazem will be given.

This outcome measures are extubation time,total propofol dose.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Awakening in Spine Surgery Patients Having Neurophysiologic Monitoring: A Comparison Study Between Clinical Signs and Bispectral Index (BIS) Guided Target Controlled Infusion(TCI) of Propofol
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bispectral index/TCI propofol/fentanyl Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. Fentanyl is used for analgesia and atracurium is used for tracheal intubation.	Device: bispectral index; Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.; Drug: Target controlled infusion of propofol; TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups; Other Names: TCI propofol ; Drug: Fentanyl; Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.; Drug: Atracurium; Atracurium 0.6 mg/kg is used for endotracheal intubation; Other Names: Tracrium
Placebo Comparator: clinical signs/TCI propofol/fentanyl Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. Fentanyl is used for analgesia and atracurium is used for tracheal intubation.	Drug: Target controlled infusion of propofol; TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups; Other Names: TCI propofol ; Drug: Fentanyl; Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.; Drug: Atracurium; Atracurium 0.6 mg/kg is used for endotracheal intubation; Other Names: Tracrium

Outcome Measures

Primary Outcome Measures

1. Extubation Time [4 hr]

   Awakening time from finished operation to endotracheal extubation.

Secondary Outcome Measures

1. Total Propofol Dosage [From start anesthesia to finish operation]

   total propofol dosage = propofol dose from start to end of the operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• spine surgery with neurophysiology monitoring

• ASA 1-3

• elective case

• cooperate patients

• Not receive drugs interfere with EEG

Exclusion Criteria:

• unstable hemodynamics

• liver disease

• propofol allergy

• BMI > 30

• complete cord lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahidol University, siriraj hospital	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Manee Raksakietisak, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT02174913
• Other Study ID Numbers: 099/2557
• First Posted: Jun 26, 2014
• Last Update Posted: Jul 13, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Mahidol University: Awakening time; Bispectral index; clinical signs; neurophysiologic monitoring; spine surgery
• Additional relevant MeSH terms: Spinal Diseases; Fentanyl; Propofol; Atracurium

Study Results

Participant Flow

Arm/Group Title	Bispectral Index	Clinical Signs
Arm/Group Description	Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.	Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
Period Title: Overall Study
STARTED	17	17
COMPLETED	17	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bispectral Index	Clinical Signs	Total
Arm/Group Description	Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.	Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.	Total of all reporting groups
Overall Participants	17	17	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.1 (11.6)	48.0 (12.1)	49.05 (11.85)
Sex: Female, Male (Count of Participants)
Female	11 64.7%	10 58.8%	21 61.8%
Male	6 35.3%	7 41.2%	13 38.2%
Region of Enrollment (participants) [Number]
Thailand	17 100%	17 100%	34 100%
Body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	62.8 (11.8)	60.4 (8.1)	61.6 (9.9)

Outcome Measures

1. Primary Outcome

Title	Extubation Time
Description	Awakening time from finished operation to endotracheal extubation.
Time Frame	4 hr

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bispectral Index	Clinical Signs
Arm/Group Description	Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.	Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
Measure Participants	17	17
Mean (Standard Deviation) [min]	16.3 (9.7)	16.6 (8.9)

2. Secondary Outcome

Title	Total Propofol Dosage
Description	total propofol dosage = propofol dose from start to end of the operation
Time Frame	From start anesthesia to finish operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bispectral Index	Clinical Signs
Arm/Group Description	Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.	Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
Measure Participants	17	17
Mean (Standard Deviation) [mg]	2,146 (742)	2,340 (839)

Adverse Events

Time Frame	From start anesthesia to 24 hr after operation.
Adverse Event Reporting Description	The cardiovascular, respiratory, neurological or other complications during the intraoperative period are recorded.
Arm/Group Title	Bispectral Index		Clinical Signs
Arm/Group Description	Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.		Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
All Cause Mortality
	Bispectral Index		Clinical Signs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Serious Adverse Events
	Bispectral Index		Clinical Signs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Bispectral Index		Clinical Signs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (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.