A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients

March 17, 2020 updated by: So Yeon Kim, Severance Hospital
Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 20
  2. Short term ventilator care after surgery in intensive care unit

Exclusion Criteria:

  1. pneumonia
  2. chronic obstructive lung disease
  3. asthma
  4. end stage renal disease
  5. risk factors for aspiration

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
stopping of propofol and remifentanil infusion
ACTIVE_COMPARATOR: Remifentanil
stopping of propofol and maintenance of remifentanil infusion
Drug: Remifentanil
Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure Changes During Extubation
Time Frame: 10 min
10 min
HR Changes During Extubation
Time Frame: 10 min
10 min
The Grade of Coughing During Extubation
Time Frame: 2 min
Grade of cough was assessed on a four-point scale (0=no coughing, 1=single cough, 2=more than one episode of nonsustained coughing, 3=sustained and repetitive coughing with head lift).
2 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Awake
Time Frame: 1 hour
Time of BIS > 80 : time between 'stopping of propofol'
1 hour
Time of Extubation
Time Frame: 1 hr
Time of extubation : time between 'stopping of propofol' and 'extubation'
1 hr

Collaborators and Investigators

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

Sponsor

Severance Hospital

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

May 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (ESTIMATE)

June 29, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 4-2010-0022

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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