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

Primary Purpose

Spine Diseases

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
bispectral index
Target controlled infusion of propofol
Fentanyl
Atracurium
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spine Diseases focused on measuring Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mahidol University, siriraj hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bispectral index/TCI propofol/fentanyl

clinical signs/TCI propofol/fentanyl

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Extubation Time
Awakening time from finished operation to endotracheal extubation.

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2014
Last Updated
June 28, 2020
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02174913
Brief Title
Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index
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 Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Diseases
Keywords
Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bispectral index/TCI propofol/fentanyl
Arm Type
Active Comparator
Arm Description
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.
Arm Title
clinical signs/TCI propofol/fentanyl
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
bispectral index
Intervention Description
Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Target controlled infusion of propofol
Other Intervention Name(s)
TCI propofol
Intervention Description
TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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
Intervention Name(s)
Atracurium
Other Intervention Name(s)
Tracrium
Intervention Description
Atracurium 0.6 mg/kg is used for endotracheal intubation
Primary Outcome Measure Information:
Title
Extubation Time
Description
Awakening time from finished operation to endotracheal extubation.
Time Frame
4 hr
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Raksakietisak, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidol University, siriraj hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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