N/A N=34 Randomized Triple-blind Other

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

Spine Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02174913 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Extubation Time — 16.3; 16.6 min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: bispectral index (Device); Target controlled infusion of propofol (Drug); Fentanyl (Drug); Atracurium (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mahidol University
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Extubation Time	16.3; 16.6	—
SECONDARY Total Propofol Dosage	2,146; 2,340	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT02174913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.