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

NCT01785446 | Unknown DMC

• 1 other identifier: Cis-123
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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.

Keywords

Dexmedetomidine; Cisatracurion infusion; Sufentanil; Recovery Index; Closed loop computer control system

Outcome Measures

Primary Outcomes (1)

• Cisatracurium infusion consumption.

  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 Outcomes (1)

• Sufentanil consumption.

  At the time of operation.

Other Outcomes (1)

• Recovery Index

  30 minutes post-operative.

Study Arms (4)

P 1

ACTIVE COMPARATOR

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.

P 2

ACTIVE COMPARATOR

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

P 3

ACTIVE COMPARATOR

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.

D

ACTIVE COMPARATOR

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

Interventions

Effect of dexmedetomidine on cisatracurium and sufentanil consumption 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.

Also known as: Dexmedetomidine

D; P 2

Consumption of cisatracurium and sufentanil in different age groups. DRUG

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

P 1; P 2; P 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead
• Shehzaad Joomye: collaborator
• Haiyun Wang: collaborator
• Donglai Yan: collaborator

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 24745306 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; cisatracurium; Sufentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Guolin Wang, MD, PhD, Professor

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shehzaad Joomye, M.D.

CONTACT

8613072283346; s_joomye@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD. Professor

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 7, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

CN (1)