The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
Information source: Korea University Anam Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Muscle Relaxants
Intervention: Rocuronium (Drug); Rocuronium (Drug); Fentanyl (Drug); propofol (Drug); sevoflurane (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Korea University Anam Hospital Official(s) and/or principal investigator(s):
Jang Eun Cho, M.D.,Ph.D., Principal Investigator, Affiliation: Anesthesia and pain medicine department, Korea University Anam Hospital
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.
Clinical Details
Official title: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Conditions during tracheal intubation
Secondary outcome: time to extubation
Detailed description:
Adenotonsillectomy in children is a short surgical procedure under general anesthesia. The
ideal muscle relaxant requires intense neuromuscular block for optimal surgical work and
complete recovery of neuromuscular function immediately after the end of the surgical
procedure without postoperative morbidity. Rocuronium is an intermediate acting
neuromuscular blockade. Reduced-dose rocuronium has been reported to provide optimal
anesthetic induction without delayed recovery. The investigators 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.
After Institutional Review Board approval and written informed consent from the parents were
obtained, 75 children (aged 3 to 10 years, ASA(The American Society of Anesthesia ) I or II)
scheduled for adenotonsillectomy were included. Anesthesia was induced with propofol 2. 5 mg
kg-1 , fentanyl 2 mcg kg-1, and rocuronium 0. 15 mg kg-1 (R 0. 15 group) or rocuronium 0. 3mg
kg-1 (R 0. 3 group) or saline (S group). After mask ventilation with 5 vol% sevoflurane in
100% oxygen for 2 minutes, tracheal intubation was done. The investigators assessed
conditions during tracheal intubation as excellent, good or poor, using five variables; jaw
relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.
The investigators added rocuronium 0. 3 mg kg-1 when there was more than one poor condition.
The investigators recorded the time from discontinuation of sevoflurane to time to
extubation.
Eligibility
Minimum age: 3 Years.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- American Society of Anesthesiologist[ASA] class 1-2
- scheduled adenotonsillectomy
- written informed consent
Exclusion Criteria:
- 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)
Locations and Contacts
Additional Information
Starting date: July 2015
Last updated: July 31, 2015
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