Clinical trial NCT01736371: Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Interaction Potentiation
Keywords: Sevoflurane
Cisatracurium infusion consumption
Closed loop computer control system
Recovery Index
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cisatracurium consumption rate.
timeFrame: At the time of surgery.
Secondary outcomes:
measure: Analysis of Means of Recovery Index.
timeFrame: 30 minutes post operative.
Other outcomes:
measure: Sufentanil Consumption.
timeFrame: At time of surgery
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Shehzaad Joomye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: