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

NCT ID: NCT01736371

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Drug Interaction Potentiation

Keywords

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Sevoflurane Cisatracurium infusion consumption Closed loop computer control system Recovery Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Total Intravenous Anesthesia

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

Group Type SHAM_COMPARATOR

Propofol

Intervention Type DRUG

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

1% Sevoflurane

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

Group Type ACTIVE_COMPARATOR

1% Sevoflurane

Intervention Type DRUG

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.

Sevoflurane

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

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Propofol

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Total Intravenous Anesthesia

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joomye Shehzaad

Joomye Shehzaad M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shehzaad Joomye, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

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Tianjin Medical University

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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Cis-sevo-123

Identifier Type: -

Identifier Source: org_study_id