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

NCT ID: NCT02174913

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

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.

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.

Conditions

Spine Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

bispectral index

Intervention Type: DEVICE

Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.

Target controlled infusion of propofol

Intervention Type: DRUG

TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups

Fentanyl

Intervention Type: DRUG

Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.

Atracurium

Intervention Type: DRUG

Atracurium 0.6 mg/kg is used for endotracheal intubation

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.

Group Type: PLACEBO_COMPARATOR

Target controlled infusion of propofol

Intervention Type: DRUG

TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups

Fentanyl

Intervention Type: DRUG

Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.

Atracurium

Intervention Type: DRUG

Atracurium 0.6 mg/kg is used for endotracheal intubation

Interventions

bispectral index

Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.

Intervention Type: DEVICE

Target controlled infusion of propofol

TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups

Intervention Type: DRUG

Fentanyl

Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.

Intervention Type: DRUG

Atracurium

Atracurium 0.6 mg/kg is used for endotracheal intubation

Intervention Type: DRUG

Other Intervention Names

TCI propofol; Tracrium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manee Raksakietisak, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Mahidol University, siriraj hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

099/2557

Identifier Type: -

Identifier Source: org_study_id