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

Tracheal Extubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152515
• Other study ID #: IRB 4-2010-0022
• Status: Completed
• Phase: Phase 4
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: March 2020
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tracheal Extubation

Intervention

Drug:
• Remifentanil
Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Arterial Pressure Changes During Extubation		10 min
Primary	HR Changes During Extubation		10 min
Primary	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	Time of Awake	Time of BIS > 80 : time between 'stopping of propofol'	1 hour
Secondary	Time of Extubation	Time of extubation : time between 'stopping of propofol' and 'extubation'	1 hr