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

Phase 4

Completed

• Conditions: Tracheal Extubation
• Interventions: Drug: Remifentanil

• Registration Number: NCT01152515
• Lead Sponsor: Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2011-04-01
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-17
• Last Update Submitted: 2020-03-17
• Results First Posted: 2020-03-18
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil	Remifentanil	stopping of propofol and maintenance of remifentanil infusion

Primary Outcome Measures

Name	Time	Method
The Grade of Coughing During Extubation	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).
HR Changes During Extubation	10 min
Mean Arterial Pressure Changes During Extubation	10 min

Secondary Outcome Measures

Name	Time	Method
Time of Awake	1 hour	Time of BIS \> 80 : time between 'stopping of propofol'
Time of Extubation	1 hr	Time of extubation : time between 'stopping of propofol' and 'extubation'

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of