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
Sponsor study identifier
interventional
34
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 12, 2014
Actual (reported)June 26, 2014
Actual (reported)February 2016
Actual (reported)February 2016
Actual (reported)July 13, 2020
Actual (reported)Extubation Time
Awakening time from finished operation to endotracheal extubation.
4 hr
Total Propofol Dosage
From start anesthesia to finish operation
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.
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Administration procedure
Target controlled infusion of propofol
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordMahidol University, siriraj hospital
Bangkok, 10700, Thailand
Manee Raksakietisak, MD
Mahidol University
34 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2014
First Posted
June 26, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?
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
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Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
July 13, 2020
Results First Posted
July 13, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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