Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.

Sponsor

Tianjin Medical University General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01736371

Collaborator

(none)

156

Enrollment

Location

Arms

Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Interaction Potentiation	Drug: 1% Sevoflurane Drug: Propofol Drug: Sevoflurane	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

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 :

Jan 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Total Intravenous Anesthesia Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55.	Drug: Propofol In this group the maintenance of anesthesia is maintained by only propofol infusion. Other Names: 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	Drug: Sevoflurane 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.

Arm

Intervention/Treatment

Sham Comparator: Total Intravenous Anesthesia

Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55.

Drug: Propofol

In this group the maintenance of anesthesia is maintained by only propofol infusion.

Other Names:

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

Drug: Sevoflurane

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.

Outcome Measures

Primary Outcome Measures

Cisatracurium consumption rate. [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.

Secondary Outcome Measures

Analysis of Means of Recovery Index. [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.

Other Outcome Measures

Sufentanil Consumption. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients aged 20 and 65.
Patients with ASA 1 and 2.
Patients for elective abdominal general surgery

Exclusion Criteria:

Patients with the following diseases are excluded, since they are known to cause generalized neuromuscular weakness:

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.