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

NCT ID: NCT01785446

Last Updated: 2013-02-07

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Brief Summary

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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

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Conditions

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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.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Consumption of cisatracurium and sufentanil in different age groups.

Intervention Type DRUG

For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.

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.

Group Type ACTIVE_COMPARATOR

Effect of dexmedetomidine on cisatracurium and sufentanil consumption

Intervention Type DRUG

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.

Consumption of cisatracurium and sufentanil in different age groups.

Intervention Type DRUG

For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.

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.

Group Type ACTIVE_COMPARATOR

Consumption of cisatracurium and sufentanil in different age groups.

Intervention Type DRUG

For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.

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.

Group Type ACTIVE_COMPARATOR

Effect of dexmedetomidine on cisatracurium and sufentanil consumption

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Dexmedetomidine

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shehzaad Joomye

UNKNOWN

Sponsor Role collaborator

Haiyun Wang

UNKNOWN

Sponsor Role collaborator

Donglai Yan

UNKNOWN

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guolin Wang, MD, PhD, Professor

M.D. PhD. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guolin Wang, MD, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

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Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shehzaad Joomye, M.D.

Role: CONTACT

8613072283346

References

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Joomye S, Yan D, Wang H, Zhou G, Wang G. Consumption of Cisatracurium in different age groups, using a closed loop computer controlled system. BMC Anesthesiol. 2014 Apr 21;14:29. doi: 10.1186/1471-2253-14-29. eCollection 2014.

Reference Type DERIVED
PMID: 24745306 (View on PubMed)

Other Identifiers

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Cis-123

Identifier Type: -

Identifier Source: org_study_id

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