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

Phase 4

• Conditions: Muscle Relaxants
• Interventions: Drug: Rocuronium bromide 0.15 mg kg-1; Drug: Rocuronium bromide 0.3 mg kg-1; Drug: Fentanyl; Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT02467595
• Lead Sponsor: Korea University Anam Hospital

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.

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-10
• Study Start: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
R 0.15 group	Rocuronium bromide 0.15 mg kg-1	Rocuronium 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 0.15 group	Fentanyl	Rocuronium 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 0.15 group	Propofol	Rocuronium 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	Rocuronium bromide 0.3 mg kg-1	Rocuronium 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.
R 0.3 group	Fentanyl	Rocuronium 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.
R 0.15 group	Sevoflurane	Rocuronium 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	Propofol	Rocuronium 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.
R 0.3 group	Sevoflurane	Rocuronium 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	Fentanyl	saline 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 .
S group	Sevoflurane	saline 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 .
S group	Propofol	saline 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 .

Primary Outcome Measures

Name	Time	Method
Conditions during tracheal intubation	At the time to tracheal intubation, after mask ventilation for 2 minutes	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.

Secondary Outcome Measures

Name	Time	Method
time to extubation	intraoperatve	When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.