- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01915108
Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal
August 21, 2014 updated by: Sangjin Park
Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal During Emergence From Sevoflurane-remifentanil Anesthesia
This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.
Study Overview
Detailed Description
Patients were randomly assigned to one of four groups.
All patients received a predetermined effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10 minutes before the end of surgery to LMA removal.
Airway complications (airway obstruction, desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the emergence phase.
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologists physical status 1 or 2
- undergoing lower extremity surgery under general anesthesia
Exclusion Criteria:
- suspected difficult airways
- respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
- body mass index > 30 kg/m2
- allergies to the study drugs
- a history of gastric reflux
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: group R0
remifentanil Ce of 0 ng/ml
|
|
Active Comparator: group R0.5
remifentanil Ce of 0.5 ng/ml
|
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Other Names:
|
Active Comparator: group R1.0
remifentanil Ce of 1.0 ng/ml
|
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Other Names:
|
Active Comparator: group R1.5
remifentanil Ce of 1.5 ng/ml
|
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Adverse Events Following LMA Removal
Time Frame: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.
|
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal.
Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.
|
from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sangjin Park, M.D., Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
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
July 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
July 23, 2013
First Submitted That Met QC Criteria
July 31, 2013
First Posted (Estimate)
August 2, 2013
Study Record Updates
Last Update Posted (Estimate)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 21, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- apsj1
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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