Optimal Sevoflurane Concentration for Intubation in Combination of Clincal Remifentanil Doses
1 other identifier
interventional
68
1 country
1
Brief Summary
Intubation is a procedure that requires well relaxed muscles while general anesthesia is performed. In order to get adequate muscle relaxation, remifentanil, sevoflurane or both agents in combination have been reported as they can provide adequate conditions for laryngoscopy and tracheal intubation without using muscle relaxants. However, there were no previous studies to find the effective dose of sevoflurane in combination with different bolus doses of remifentanil to obtain adequate endotracheal intubation conditions without using muscle relaxants. The aim of this study is to investigate the change in the minimum sevoflurane alveolar concentration which produces an adequate endotracheal intubation condition when sevoflurane is combined with different bolus doses of remifentanil used in clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started May 2015
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, 2015
CompletedFirst Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
January 17, 2019
CompletedJanuary 17, 2019
July 1, 2018
11 months
May 5, 2015
July 20, 2017
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EC50 for Successful Intubation in Each Groups
Sevoflurane concentration used to perform intubation (For ED50 finding)
During the induction of anesthesia
Secondary Outcomes (1)
EC95 for Successful Intubation
During the induction of anesthesia
Study Arms (3)
Remifentanil 1.0 mcg/kg
ACTIVE COMPARATORAfter setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil 1.5 mcg/kg
ACTIVE COMPARATORAfter setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Remifentanil 2.0 mcg/kg
ACTIVE COMPARATORAfter setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
Interventions
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists physical status I or II who were scheduled to undergo elective otolaryngological surgery
You may not qualify if:
- history of reactive airway disease
- smoking hx.
- a predictive signs of difficult intubation
- body mass index ≥ 30 kg•m-2 or ≤ 15 kg•m-2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Armed Forces Capital Hospital, Republic of Korea
Seongnam-si, Kyung-ki Do, South Korea
Related Publications (3)
Cros AM, Lopez C, Kandel T, Sztark F. Determination of sevoflurane alveolar concentration for tracheal intubation with remifentanil, and no muscle relaxant. Anaesthesia. 2000 Oct;55(10):965-9. doi: 10.1046/j.1365-2044.2000.01538.x.
PMID: 11012491BACKGROUNDMin SK, Kwak YL, Park SY, Kim JS, Kim JY. The optimal dose of remifentanil for intubation during sevoflurane induction without neuromuscular blockade in children. Anaesthesia. 2007 May;62(5):446-50. doi: 10.1111/j.1365-2044.2007.05037.x.
PMID: 17448054BACKGROUNDDixon WJ. Staircase bioassay: the up-and-down method. Neurosci Biobehav Rev. 1991 Spring;15(1):47-50. doi: 10.1016/s0149-7634(05)80090-9.
PMID: 2052197RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jae Chul Koh
- Organization
- Severance
Study Officials
- STUDY DIRECTOR
Eui-Kyoung Goo, MD
Armed forces capital hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow, Department of anesthesiology and pain medicine
Study Record Dates
First Submitted
May 5, 2015
First Posted
May 12, 2015
Study Start
May 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
January 17, 2019
Results First Posted
January 17, 2019
Record last verified: 2018-07