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

Korea University

Status and phase: Unknown; Phase 4

Conditions: Muscle Relaxants

Treatments: Drug: Rocuronium bromide 0.3 mg kg-1; Drug: Propofol; Drug: Fentanyl; Drug: Rocuronium bromide 0.15 mg kg-1; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT02467595

ED14142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

R 0.15 group

Experimental group

Description:

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.

Treatment:

Drug: Sevoflurane

Drug: Fentanyl

Drug: Rocuronium bromide 0.15 mg kg-1

Drug: Propofol

R 0.3 group

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane

Drug: Fentanyl

Drug: Propofol

Drug: Rocuronium bromide 0.3 mg kg-1

S group

Placebo Comparator group

Description:

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 .

Treatment:

Drug: Sevoflurane

Drug: Fentanyl

Drug: Propofol