Effect of Remifentanil on Cough During Emergence From General Anesthesia : Trial to Compare Between Sevoflurane Anesthesia and Propofol Anesthesia

May 12, 2011 updated by: Yonsei University

Effect of Remifentanil on Cough During Emergence From General Anesthesia : Randomized Trial to Comparison Between Sevoflurane Anesthesia and Propofol Anesthesia

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.

Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.

However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex.

Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Recent reporters suggest that antitussive effect of remifentanil differs depend on main anesthetic agents, the incidence of coughing when tracheal extubation is reduced after propofol anesthesia compared with sevoflurane anesthesia.

However, these studies raise important questions about failure of maintaining the same effect site concentration of remifentanil in both groups.

The objective of this study was to compare the effect of remifentanil on suppression cough reflex during emergence in patient anesthetized using either propofol or sevoflurane additionally under infusion of the identical concentration of remifentanil.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • females
  • ASA I-II
  • aged between 20 and 70 year
  • general anesthesia for elective thyroidectomy

Exclusion Criteria:

  • signs of an anatomical or functional abnormality in upper airway
  • risk factors for perioperative aspiration
  • smoking for recent 8 weeks
  • URI or sore throat for recent 2 weeks
  • potential of pregnancy

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
Active Comparator: propofol
Drug: Remifentanil
  • propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml
  • sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml
Other Names:
  • Ultiva
Active Comparator: sevoflurane
Drug: Remifentanil
  • propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml
  • sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml
Other Names:
  • Ultiva

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Jeong-Rim Lee, MD, Ph.D, Severance Hospital, Department of Anesthesiology and Pain Medicine

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

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 12, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0369

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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