Study of Cisatracurium and Sufentanil Consumption Using a Closed Loop Computer Control Infusion System

Tianjin Medical University

Status: Unknown

Conditions: The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index.; Effect of Dexmedetomidine on Sufentanil Consumption.; Quantitative Analysis of Cisatracurium Infusion Requirements, Sufentanil Consumption and Recovery Index in Different Age Groups.

Treatments: Drug: Consumption of cisatracurium and sufentanil in different age groups.; Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT01785446

Cis-123

Details and patient eligibility

About

The purpose of this study is to:

• determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption.
• analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA status 1 and 2.
• Consent approval written and oral.
• Patients scheduled for elective abdominal surgery under general anesthesia.

Exclusion criteria

• Patients with neuromuscular disorders.
• Patients with history of stroke, flaccid paralysis or other neurological disorders.
• Significant renal, hepatic or cardiac dysfunction.
• Consent refusal.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 4 patient groups

P 1

Active Comparator group

Description:

In this group patients were aged from 20 to 45. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Treatment:

Drug: Consumption of cisatracurium and sufentanil in different age groups.

P 2

Active Comparator group

Description:

In this group patients were aged from 46 to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Treatment:

Drug: Consumption of cisatracurium and sufentanil in different age groups.

Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption

P 3

Active Comparator group

Description:

In this group patients were aged from 66 to 85. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Treatment:

Drug: Consumption of cisatracurium and sufentanil in different age groups.

D

Active Comparator group

Description:

In this group patients were aged from 46to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Dexmedetomidine infusion is started at induction,a bolus dose of 0.5 µg/kg is given over the first hour which is followed by infusion of 0.4 µg/kg/hr. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis.

Treatment:

Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption