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

This study has been completed.
Sponsor:
Information provided by:
Severance Hospital
ClinicalTrials.gov Identifier:
NCT01152515
First received: June 28, 2010
Last updated: March 10, 2011
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Tracheal Extubation
 Drug: Remifentanil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients

Resource links provided by NLM:

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Cardiovascular response during extubation [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]
    1. Heart rate and mean arterial pressure at extubation and 5, 10 min from extubation
    2. Coughing grade at extubation (0 = no coughing, 1 = a single cough, 2 = more than one episode of non-sustained coughing, 3 = sustained and repetitive coughing with head lift)


Secondary Outcome Measures:
  • Time of awake and extubation [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Time of BIS > 80 : time between 'stopping of propofol' and Time of extubation : time between 'stopping of propofol' and 'extubation'


Estimated Enrollment: 50
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
stopping of propofol and remifentanil infusion
 Drug: Remifentanil
Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152515

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Severance Hospital
  More Information

No publications provided

Responsible Party: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT01152515     History of Changes
Other Study ID Numbers: IRB 4-2010-0022
Study First Received: June 28, 2010
Last Updated: March 10, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Severance Hospital:
safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery

Additional relevant MeSH terms:
Propofol
Remifentanil
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013