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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02174913
Enrollment
34
Registered
2014-06-26
Start date
2014-05-31
Completion date
2016-02-29
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine Diseases

Keywords

Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery

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.

Interventions

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

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

DRUGFentanyl

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

Atracurium 0.6 mg/kg is used for endotracheal intubation

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Extubation Time4 hrAwakening time from finished operation to endotracheal extubation.

Secondary

MeasureTime frameDescription
Total Propofol DosageFrom start anesthesia to finish operationtotal propofol dosage = propofol dose from start to end of the operation

Countries

Thailand

Participant flow

Participants by arm

ArmCount
Bispectral Index
Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
17
Clinical Signs
Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
17
Total34

Baseline characteristics

CharacteristicBispectral IndexClinical SignsTotal
Age, Continuous50.1 years
STANDARD_DEVIATION 11.6
48.0 years
STANDARD_DEVIATION 12.1
49.05 years
STANDARD_DEVIATION 11.85
Body weight62.8 kg
STANDARD_DEVIATION 11.8
60.4 kg
STANDARD_DEVIATION 8.1
61.6 kg
STANDARD_DEVIATION 9.9
Region of Enrollment
Thailand
17 participants17 participants34 participants
Sex: Female, Male
Female
11 Participants10 Participants21 Participants
Sex: Female, Male
Male
6 Participants7 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 17
other
Total, other adverse events
0 / 170 / 17
serious
Total, serious adverse events
0 / 170 / 17

Outcome results

Primary

Extubation Time

Awakening time from finished operation to endotracheal extubation.

Time frame: 4 hr

ArmMeasureValue (MEAN)Dispersion
Bispectral IndexExtubation Time16.3 minStandard Deviation 9.7
Clinical SignsExtubation Time16.6 minStandard Deviation 8.9
Secondary

Total Propofol Dosage

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

Time frame: From start anesthesia to finish operation

ArmMeasureValue (MEAN)Dispersion
Bispectral IndexTotal Propofol Dosage2,146 mgStandard Deviation 742
Clinical SignsTotal Propofol Dosage2,340 mgStandard Deviation 839

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026