Comparison Between Remifentanil Target-controlled Infusion and Dexmedetomidine Bolus Administration for Smooth Emergence From General Sevoflurane Anesthesia

June 11, 2012 updated by: Yonsei University
Remifentanil target-controlled infusion and dexmedetomidine single-dose administration are known to reduce airway response and haemodynamic stimulation during anaesthetic recovery. The investigators will compare the effects of two drugs on prevention of cough during emergence from general sevoflurane anaesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

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

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patient,
  • aged 20-60 yr,
  • ASA physical status 1-2,
  • patients undergoing elective thyroidectomy under general anesthesia

Exclusion Criteria:

  • sighs of difficult airway,
  • history of respiratory disease or chronic cough,
  • cardiovascular disease,
  • pregnant or breast-feeding woman.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group R
continuation of remifentanil target controlled infusion (TCI) at effect-site concentration of 2 ng/ml during anesthetic recovery until extubation.
Drug: Normal Saline
Drug: dexmedetomidine
Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.
Active Comparator: group D
remifentanil TCI discontinuation and dexmedetomidine 0.5 mg/kg intravenous injection before 10 min of the end of surgery
Drug: Normal Saline
Drug: dexmedetomidine
Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coughing response
Time Frame: from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.
Emergence cough was defined as the cough occurrence during peri-extubation period, from sevoflurane discontinuation to 5 min after extubation. The severity of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).
from discontinuation of anesthetic agent (sevoflurane) to 5 min after extubation.

Collaborators and Investigators

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

Sponsor

Yonsei University

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

June 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2011-0181

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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