- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02467595
The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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:
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Names:
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Names:
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Names:
|
Active Comparator: R 0.3 group
Rocuronium bromide 0.3 mg kg-1 group
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:
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Names:
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Names:
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:
|
Placebo Comparator: S group
saline
|
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Names:
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Names:
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Jang Eun Cho, M.D.,Ph.D., Anesthesia and pain medicine department, Korea University Anam Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Muscle Hypotonia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anticonvulsants
- Anesthetics, Inhalation
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Fentanyl
- Propofol
- Sevoflurane
- Bromides
- Rocuronium
Other Study ID Numbers
- ED14142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Muscle Relaxants
-
Huazhong University of Science and TechnologyNot yet recruitingNondepolarising Muscle RelaxantsChina
-
Hospital Sultanah Aminah Johor BahruCompletedUnderdosing of Skeletal Muscle Relaxants for Laparotomy | Reversal of Skeletal Muscle RelaxantMalaysia
-
Ain Shams UniversityCompletedEntropy Device and How Will Muscle Relaxants Affect itEgypt
-
Prince of Songkla UniversityCompletedComparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle RelaxantMuscle RelaxantThailand
-
Mansoura UniversityRecruiting
-
University of Toledo Health Science CampusCompleted
-
Puerta de Hierro University HospitalCompleted
-
Shashi Bhatt, MDWithdrawnMuscle RelaxantsUnited States
-
Indonesia UniversityCompletedGeneral Anesthesia | Muscle RelaxantIndonesia
-
King Saud UniversityCompletedAnesthesia Intubation ComplicationSaudi Arabia
Clinical Trials on Rocuronium bromide 0.15 mg kg-1
-
Merck Sharp & Dohme LLCCompleted
-
Thomas SchrickerMerck Sharp & Dohme LLCTerminatedHigh-Frequency Jet Ventilation | Vocal Cord ResectionCanada
-
Medtronic - MITGCompletedAnesthesia | Neuromuscular BlockadeUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Aileron Therapeutics, Inc.Completed
-
University of RostockCompletedObservation of Neuromuscular Block | Complication of Ventilation TherapyGermany
-
The First Affiliated Hospital with Nanjing Medical...Wu Jieping Medical FoundationCompleted
-
BioMarin PharmaceuticalTerminatedDuchenne Muscular DystrophyBelgium, Netherlands, France, United Kingdom, Italy
-
University of California, DavisCompletedSurgeryUnited States
-
The Catholic University of KoreaUnknownMuscle Weakness | Neuromuscular Block | Orthopedic Disorder of SpineKorea, Republic of