A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
March 18, 2020
CompletedMarch 27, 2020
March 1, 2020
9 months
June 28, 2010
April 1, 2011
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean Arterial Pressure Changes During Extubation
10 min
HR Changes During Extubation
10 min
The Grade of Coughing During Extubation
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 Outcomes (2)
Time of Awake
1 hour
Time of Extubation
1 hr
Study Arms (2)
Control
NO INTERVENTIONstopping of propofol and remifentanil infusion
Remifentanil
ACTIVE COMPARATORstopping of propofol and maintenance of remifentanil infusion
Interventions
Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion
Eligibility Criteria
You may qualify if:
- Age ≥ 20
- Short term ventilator care after surgery in intensive care unit
You may not qualify if:
- pneumonia
- chronic obstructive lung disease
- asthma
- end stage renal disease
- risk factors for aspiration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Shin Ok Koh
- Organization
- Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
March 27, 2020
Results First Posted
March 18, 2020
Record last verified: 2020-03