Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
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|ClinicalTrials.gov Identifier: NCT01736371|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : November 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Drug Interaction Potentiation||Drug: 1% Sevoflurane Drug: Propofol Drug: Sevoflurane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Sham Comparator: Total Intravenous Anesthesia
Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55.
In this group the maintenance of anesthesia is maintained by only propofol infusion.
Other Name: Total Intravenous Anesthesia
Active Comparator: 1% Sevoflurane
1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion.
Drug: 1% Sevoflurane
In this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index.
Active Comparator: Sevoflurane
Only Sevoflurane is used for maintenance keeping BIS between 45-55
In this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55.
- Cisatracurium consumption rate. [ Time Frame: At the time of surgery. ]Measurements were done intraoperatively. Investigators obtained data from the closed loop computer system, from which the intra-operative consumption of cisatracurium were obtained from each patient. Data were collected only during surgery. Each patient had different cisatracurium consumption rate, and the mean consumption rate of the patients within the same group were calculated, and compared with the means from the other groups.
- Analysis of Means of Recovery Index. [ Time Frame: 30 minutes post operative. ]Recovery Index was the time for the Train-Of-Four ratio (TOF) to increase from 25% to 75%. The TOF ratio was recorded every minute till it reached 90%. Time taken for each patient was from 5 to 25 minutes. Investigators compared the average recovery index of patients from each group.
- Sufentanil Consumption. [ Time Frame: At time of surgery ]Measurements were done intraoperatively, from which the intra-operative consumption of sufentanil were obtained from each patient. Data were collected only during surgery. Investigators compared the average sufentanil consumption between between groups.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736371
|Tianjin Medical University|
|Tianjin, China, 300070|
|Principal Investigator:||Shehzaad Joomye, M.D.||Tianjin Medical University General Hospital|