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

Tianjin Medical University

Status: Completed

Conditions: Drug Interaction Potentiation

Treatments: Drug: 1% Sevoflurane; Drug: Sevoflurane; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01736371

Cis-sevo-123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 3 patient groups

Total Intravenous Anesthesia

Sham Comparator group

Description:

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

Treatment:

Drug: Propofol

1% Sevoflurane

Active Comparator group

Description:

1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion.

Treatment:

Drug: 1% Sevoflurane

Sevoflurane

Active Comparator group

Description:

Only Sevoflurane is used for maintenance keeping BIS between 45-55

Treatment:

Drug: Sevoflurane