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The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy

The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02467595
Enrollment
75
Registered
2015-06-10
Start date
2015-07-31
Completion date
2016-12-31
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Relaxants

Keywords

no muscle relaxant, rocuronium, intubation condition, tracheal intubation, operating room time, low-dose rocuronium

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.

Interventions

DRUGRocuronium bromide 0.15 mg kg-1

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.

DRUGRocuronium bromide 0.3 mg kg-1

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.

DRUGFentanyl

Fentanyl 2 mcg kg-1 was injected at I.V. line to patients

DRUGPropofol

Propofol 2.5 mg kg-1 was injected at I.V. line to patients

DRUGSevoflurane

After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.

Sponsors

Korea University Anam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Conditions during tracheal intubationAt the time to tracheal intubation, after mask ventilation for 2 minutesWe 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.

Secondary

MeasureTime frameDescription
time to extubationintraoperatveWhen surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.

Other

MeasureTime frameDescription
Additive rocuroniumintraoperatveWe added rocuronium 0.3 mg kg-1 when there was more than one poor intubating condition.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026