Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia

April 4, 2014 updated by: Chongwha Baek, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-60
  • patients undergoing elective surgery take more than an hour
  • Under general anesthesia using an LMA
  • ASA I,II

Exclusion Criteria:

  • Patients on CNS depressants
  • Chronic opioid use
  • Corticosteroid
  • Pregnant patients
  • Full stomach
  • Morbidly obese (BMI >35kg/m2)
  • Hepatitis B
  • Hepatitis C
  • Coronary artery disease
  • Liver disease
  • Renal disease
  • Seizure disorder

Dropout criteria:

  • Need for reintubation due to breath holding
  • high ETCO2 during self ventilation (ETCO2>50)
  • Surgeon or patient request

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desflurane group
1.5 MAC desflurane until extubation
Drug: Desflurane
During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
Other Names:
  • Desflurane alone group
Active Comparator: Desflurane with remifentanil group
1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil
Drug: Desflurane with remifentanil
During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil
Other Names:
  • desflurane with remifetanil group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awakening Time
Time Frame: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.
The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening
Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate & Complication Rate Including Cough
Time Frame: assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.
We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.
assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.
The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)
Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.

Collaborators and Investigators

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

Sponsor

Chung-Ang University Hosptial, Chung-Ang University College of 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

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • deep extubation in CAUH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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