Clinical trial NCT02467595: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
Official title: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Muscle Relaxants
Keywords: no muscle relaxant
rocuronium
intubation condition
tracheal intubation
operating room time
low-dose rocuronium
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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)

Primary outcomes:
measure: Conditions during tracheal intubation
timeFrame: At the time to tracheal intubation, after mask ventilation for 2 minutes
Secondary outcomes:
measure: time to extubation
timeFrame: intraoperatve
Other outcomes:
measure: Additive rocuronium
timeFrame: intraoperatve
Locations:
Study officials:
affiliation: Anesthesia and pain medicine department, Korea University Anam Hospital
name: Jang Eun Cho, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.