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

Not Applicable

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

• Registration Number: NCT01785446
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study First Submitted: 2013-02-04
• Study First Submitted QC: 2013-02-06
• Last Update Submitted: 2013-02-06
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P 3	Consumption of cisatracurium and sufentanil in different age groups.	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.
D	Effect of dexmedetomidine on cisatracurium and sufentanil consumption	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.
P 2	Effect of dexmedetomidine on cisatracurium and sufentanil consumption	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.
P 2	Consumption of cisatracurium and sufentanil in different age groups.	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.
P 1	Consumption of cisatracurium and sufentanil in different age groups.	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.

Primary Outcome Measures

Name	Time	Method
Cisatracurium infusion consumption.	At the time of surgery	Measurements were done during the operation. Cisatracurium infusion was controlled a closed loop computer system. The degree of neuromuscular blockage was assessed every 20 seconds throughout the procedure using the train of four testing. It was done by counting the number and amplitude of twitches evoked after electrical stimulus and the rate of infusion maintained itself at the low rate of 0.20µg/kg/min as long as the T1 response is less than 1%. When the T1 \> 1%, the rate of infusion would automatically increase to 5.0 µg/kg/min until T1 \< 1%, after which the infusion rate would fall back to 0.20µg/kg/min. The controlled infusion described above administered small doses of cisatracurium intra-operatively to maintain a muscle relaxation of more than 99%. The system saved the time and amount of drug given throughout the operation, from which the consumption was calculated in µg/kg/min.

Secondary Outcome Measures

Name	Time	Method
Sufentanil consumption.	At the time of operation.	Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil when the pulse and blood pressure would increase by more than 20% of the baseline, and BIS in the required range, as this would indicate an increase perception of pain but adequate anaesthesia. Sufentanil consumption was calculated for each patient in µg/kg/hr and the length of the operation was determined as from induction to the time of skin closure.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China