NCT02283866|Completed
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Sponsor study identifier
interventional
48
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Balanced anesthesia combining volatile anesthetics and opioids is commonly used in modern anesthesia. The purpose of this study is to compare two methods of administering desflurane, an volatile anesthetic during balanced anesthesia. The investigators hypothesized that administering desflurane at 1 MAC (minimum alveolar concentration) during balanced anesthesia will be more beneficial in terms of stability of the patient's vital signs and hypnotic depth than administering desflurane according to the patient's BIS (bispectral index) value.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
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.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 2014
Actual (reported)November 5, 2014
Actual (reported)March 2015
Actual (reported)March 2015
Actual (reported)The difference of 'wobble' value of the patients' BIS value between the two groups
'Wobble' is a variable that can measure the performance measurement of a pharmacokinetic model, or the reaction of the patient to a drug. We can calculate the performance error from the target of the therapy and the actual measured value, and derive the wobble by a specific formulas, which are described below. PE=(BISmeasured-BIStargeted)x100/BIStargeted MDPEi = median{PEij, j=1,…,Ni} MDAPEi = median{\|PEij\|, j=1,…,Ni} Wobblei = median{\|PEij-MDPEi\|, j=1,…,Ni} Divergence = slope{\|PEij\|, j=1,…,Ni}
Every second from 10 minutes after skin incision to 10 minutes before surgery end.
The difference of 'wobble' value of the patients' systolic arterial blood pressure value between the two groups
Every 2.5 minutes from 10 minutes after skin incision to 10 minutes before surgery end
Eye opening time to prodding after stopping of anesthetics.
1 min,2 min,3 min, 4min, 5min, 6min, 7min, 8min, 9min, 10min after stopping injection of anesthetics
The anesthesiologist administers the volatile anesthetic desflurane to set the patient's BIS value at 50 during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.
The anesthesiologist administers the volatile anesthetic desflurane at 1 MAC during balanced anesthesia, and titrate the remifentanil dose to set the patient's systolic arterial blood pressure between 100-140mmHg.
Administering desflurane according to the patient's BIS value
Administering desflurane at 1 MAC
Seoul National University Hospital
Seoul, South Korea
Yang SM, Jung YS, Jung CW, Kim WH, Yoon SB, Lee HC. Comparison of bispectral index-guided and fixed-gas concentration techniques in desflurane and remifentanil anesthesia: A randomized controlled trial. PLoS One. 2020 Nov 5;15(11):e0241828. doi: 10.1371/journal.pone.0241828. eCollection 2020.
Chul-Woo Jung
Seoul National University Hospital
48 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2014
First Posted
November 5, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
July 15, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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