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

Drug Interaction Potentiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736371
• Other study ID #: Cis-sevo-123
• Status: Completed
• Phase: N/A
• First received: November 25, 2012
• Last updated: November 28, 2012
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

• Patients who are sent intubated to ICU after surgery.

• Patients refusal

Related Conditions & MeSH terms

• Drug Interaction Potentiation

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical University	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	At time of surgery
Primary	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.	At the time of surgery.
Secondary	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.	30 minutes post operative.