NCT02174913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

July 13, 2020

Completed
Last Updated

July 13, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

June 12, 2014

Results QC Date

September 19, 2016

Last Update Submit

June 28, 2020

Conditions

Spine Diseases

Keywords

Awakening timeBispectral indexclinical signsneurophysiologic monitoringspine surgery

Outcome Measures

Primary Outcomes (1)

  • Extubation Time

    Awakening time from finished operation to endotracheal extubation.

    4 hr

Secondary Outcomes (1)

  • Total Propofol Dosage

    From start anesthesia to finish operation

Study Arms (2)

bispectral index/TCI propofol/fentanyl

ACTIVE COMPARATOR

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 indexDrug: Target controlled infusion of propofolDrug: FentanylDrug: Atracurium

clinical signs/TCI propofol/fentanyl

PLACEBO COMPARATOR

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 propofolDrug: FentanylDrug: Atracurium

Interventions

bispectral indexDEVICE

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

bispectral index/TCI propofol/fentanyl
Target controlled infusion of propofolDRUG

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

Also known as: TCI propofol
bispectral index/TCI propofol/fentanylclinical signs/TCI propofol/fentanyl
FentanylDRUG

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

bispectral index/TCI propofol/fentanylclinical signs/TCI propofol/fentanyl
AtracuriumDRUG

Atracurium 0.6 mg/kg is used for endotracheal intubation

Also known as: Tracrium
bispectral index/TCI propofol/fentanylclinical signs/TCI propofol/fentanyl

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • spine surgery with neurophysiology monitoring
  • ASA 1-3
  • elective case
  • cooperate patients
  • Not receive drugs interfere with EEG

You may not qualify if:

  • unstable hemodynamics
  • liver disease
  • propofol allergy
  • BMI \> 30
  • complete cord lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University, siriraj hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Spinal DiseasesSigns and Symptoms

Interventions

Consciousness MonitorsFentanylAtracurium

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and SuppliesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Department of Anesthesiology, Siriraj Hospital
Organization
Mahidol University
manee95@hotmail.com
66-2-41979889

Study Officials

  • Manee Raksakietisak, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 26, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 13, 2020

Results First Posted

July 13, 2020

Record last verified: 2020-06

Locations

TH(1)