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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle Relaxants

Intervention / Treatment
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* Drug: Rocuronium bromide 0.15 mg kg-1
* Drug: Rocuronium bromide 0.3 mg kg-1
* Drug: Fentanyl
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R 0.15 group<br>Rocuronium bromide 0.15 mg kg-1 group Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1 After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 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. | Drug: Rocuronium bromide 0.15 mg kg-1<br>* 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.<br>* Other names: Esmerone;Drug: Fentanyl<br>* Fentanyl 2 mcg kg-1 was injected at I.V. line to patients<br>* Other names: 하나구연산펜타닐주사;Drug: Propofol<br>* Propofol 2.5 mg kg-1 was injected at I.V. line to patients<br>* Other names: Fresofol MCT 1%;Drug: Sevoflurane<br>* After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.<br>* Other names: 세보프란 흡입액;|
| Active Comparator: R 0.3 group<br>Rocuronium bromide 0.3 mg kg-1 group Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1 After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. 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. | Drug: Rocuronium bromide 0.3 mg kg-1<br>* 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.<br>* Other names: Esmerone;Drug: Fentanyl<br>* Fentanyl 2 mcg kg-1 was injected at I.V. line to patients<br>* Other names: 하나구연산펜타닐주사;Drug: Propofol<br>* Propofol 2.5 mg kg-1 was injected at I.V. line to patients<br>* Other names: Fresofol MCT 1%;Drug: Sevoflurane<br>* After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.<br>* Other names: 세보프란 흡입액;|
| Placebo Comparator: S group<br>saline Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 . | Drug: Fentanyl<br>* Fentanyl 2 mcg kg-1 was injected at I.V. line to patients<br>* Other names: 하나구연산펜타닐주사;Drug: Propofol<br>* Propofol 2.5 mg kg-1 was injected at I.V. line to patients<br>* Other names: Fresofol MCT 1%;Drug: Sevoflurane<br>* After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.<br>* Other names: 세보프란 흡입액;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to extubation | When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation. | intraoperatve | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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no muscle relaxant, rocuronium, intubation condition, tracheal intubation, operating room time, low-dose rocuronium