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

Muscle Relaxants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02467595
• Other study ID #: ED14142
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 11, 2015
• Last updated: January 26, 2016
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Muscle Hypotonia
• Muscle Relaxants

Intervention

Drug:
• Rocuronium 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.
• Rocuronium 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.
• Fentanyl
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
• Propofol
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
• Sevoflurane
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Additive rocuronium	We added rocuronium 0.3 mg kg-1 when there was more than one poor intubating condition.	intraoperatve	No
Primary	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	No
Secondary	time to extubation	When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.	intraoperatve	No