Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal
1 other identifier
interventional
128
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
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
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedResults Posted
Study results publicly available
August 25, 2014
CompletedAugust 25, 2014
August 1, 2014
11 months
July 23, 2013
July 13, 2014
August 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Adverse Events Following LMA Removal
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.
Study Arms (4)
group R0
NO INTERVENTIONremifentanil Ce of 0 ng/ml
group R0.5
ACTIVE COMPARATORremifentanil Ce of 0.5 ng/ml
group R1.0
ACTIVE COMPARATORremifentanil Ce of 1.0 ng/ml
group R1.5
ACTIVE COMPARATORremifentanil Ce of 1.5 ng/ml
Interventions
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).
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status 1 or 2
- undergoing lower extremity surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sangjin Parklead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sangjin Park
- Organization
- assistant professor
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
July 23, 2013
First Posted
August 2, 2013
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 25, 2014
Results First Posted
August 25, 2014
Record last verified: 2014-08