The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2015
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
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 27, 2016
January 1, 2016
1.3 years
May 11, 2015
January 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Conditions during tracheal intubation
We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.
At the time to tracheal intubation, after mask ventilation for 2 minutes
Secondary Outcomes (1)
time to extubation
intraoperatve
Other Outcomes (1)
Additive rocuronium
intraoperatve
Study Arms (3)
R 0.15 group
EXPERIMENTALRocuronium bromide 0.15 mg kg-1 group 1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1 2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. 3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.
R 0.3 group
ACTIVE COMPARATORRocuronium bromide 0.3 mg kg-1 group 1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1 2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. 3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 4. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.
S group
PLACEBO COMPARATORsaline 1. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline. 2. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. 3. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 4. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 .
Interventions
Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.
Rocuronium 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologist\[ASA\] class 1-2
- scheduled adenotonsillectomy
- written informed consent
You may not qualify if:
- allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
- known or suspected upper respiratory infection
- disorder affecting neuromuscular blockade
- suspected difficult tracheal intubation
- Developmental Disability
- known or suspected psychologic disorder
- medication (psychoactive drugs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Huh H, Park JJ, Kim JY, Kim TH, Yoon SZ, Shin HW, Lee HW, Lim HJ, Cho JE. Optimal dose of rocuronium bromide undergoing adenotonsillectomy under 5% sevoflurane with fentanyl. Int J Pediatr Otorhinolaryngol. 2017 Oct;101:70-74. doi: 10.1016/j.ijporl.2017.07.030. Epub 2017 Jul 25.
PMID: 28964314DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jang Eun Cho, M.D.,Ph.D.
Anesthesia and pain medicine department, Korea University Anam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
May 11, 2015
First Posted
June 10, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
January 27, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share