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

February 6, 2013 updated by: Guolin Wang, MD, PhD, Professor, Tianjin Medical University General Hospital

Effect of Dexmedetomidine on Cisatracurium Infusion and Sufentanil Consumption and Its Variations in Different Age Groups, Using a Closed Loop Computer Controlled System.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Sub-Investigator:
          • Haiyun Wang, MD, PhD
        • Principal Investigator:
          • Guolin Wang, MD, PhD, Professor
        • Principal Investigator:
          • Shehzaad Joomye, MD
        • Sub-Investigator:
          • Donglai Yan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: P 1

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.
Drug: Consumption of cisatracurium and sufentanil in different age groups.
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.
ACTIVE_COMPARATOR: P 2

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.
Drug: Consumption of cisatracurium and sufentanil in different age groups.
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.
Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption
In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
Other Names:
  • Dexmedetomidine
ACTIVE_COMPARATOR: P 3

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.
Drug: Consumption of cisatracurium and sufentanil in different age groups.
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.
ACTIVE_COMPARATOR: D

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.
Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption
In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
Other Names:
  • Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cisatracurium infusion consumption.
Time Frame: 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.
At the time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sufentanil consumption.
Time Frame: 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.
At the time of operation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery Index
Time Frame: 30 minutes post-operative.
Recovery Index, time for the Train-Of-Four (TOF) value to increase from 25% to 75%, was measured in each patient who completed the study. Its measurements were recorded in minutes.
30 minutes post-operative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University General Hospital

Collaborators

Shehzaad Joomye
Haiyun Wang
Donglai Yan

Investigators

  • Principal Investigator: Guolin Wang, MD, PhD, Professor, Tianjin Medical University General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (ESTIMATE)

February 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cis-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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