An interventional study of 1% Sevoflurane and Propofol in Drug Interaction Potentiation, sponsored by Tianjin Medical University General Hospital. Completed at 1 site in China. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-29.
Sponsored by Tianjin Medical University General Hospital · Not applicable, Interventional, and Basic science
The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Investigators further investigated this effect on its recovery period and sufentanyl consumption.
156 patients of American Society of Anesthesiologists (ASA) physical status I and II were assigned to three groups. The patients were all on schedule for elective general surgery under general anesthesia with duration of at two to four hours. All patients were induced with Etomidate (0.2mg/kg), Midazolam (0.05-0.1mg/kg), Sufentanil (0.3-0.5µg/kg) and a bolus dose of Cisatracurium (0.15mg/kg). Patients were aged between 20 and 65. The maintenance of anesthesia in each group varies as follows: Patients in Group 1 were all maintained with Total Intravenous Anesthesia, Group 2 with Sevoflurane at 1% and propofol infusion, Group 3 with only sevoflurane. Muscle paralysis is maintained using a closed-loop computer gated infusion of Cisatracurium which kept T1 \<1% by giving increasing the infusion rate intra-operatively when required. Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil.
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Exclusion Criteria:
Neuromuscular junction disorders (e.g.. myasthenia gravis) Myopathies (e.g.. Muscular Dystrophies, Rhabdomyolysis) Peripheral Neuropathies (e.g. Guillain-Barre Syndrome, Polyneuropathies) Encephalopathies (Septic and Toxic-metabolic Encephalopathy) Patients with renal and liver diseases.
Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55.
Drug: Propofol
1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion.
Drug: 1% Sevoflurane
Only Sevoflurane is used for maintenance keeping BIS between 45-55
Drug: 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.
In this group the maintenance of anesthesia is maintained by only propofol infusion.
Also known as: Total Intravenous Anesthesia
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.
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.
Time frame: At the time of surgery.
Analysis of Means of Recovery Index.
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.
Time frame: 30 minutes post operative.
Sufentanil Consumption.
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.
Time frame: At time of surgery
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University General Hospital