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

January 26, 2016 updated by: Sangjae Park, Korea University Anam Hospital

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: R 0.15 group

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.

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.
Other Names:
  • Esmerone
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Names:
  • 하나구연산펜타닐주사
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Names:
  • Fresofol MCT 1%
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Names:
  • 세보프란 흡입액
Active Comparator: R 0.3 group

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.

Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Names:
  • 하나구연산펜타닐주사
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Names:
  • Fresofol MCT 1%
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Names:
  • 세보프란 흡입액
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.
Other Names:
  • Esmerone
Placebo Comparator: S group

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 .
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Names:
  • 하나구연산펜타닐주사
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Names:
  • Fresofol MCT 1%
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Names:
  • 세보프란 흡입액

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditions during tracheal intubation
Time Frame: 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.
At the time to tracheal intubation, after mask ventilation for 2 minutes

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additive rocuronium
Time Frame: intraoperatve
We added rocuronium 0.3 mg kg-1 when there was more than one poor intubating condition.
intraoperatve

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jang Eun Cho, M.D.,Ph.D., Anesthesia and pain medicine department, Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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