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

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ClinicalTrials.gov Identifier: NCT02467595
Recruitment Status : Unknown
Verified January 2016 by Sangjae Park, Korea University Anam Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 10, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Sangjae Park, 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.

Condition or disease Intervention/treatment Phase
Muscle Relaxants Drug: Rocuronium bromide 0.15 mg kg-1 Drug: Rocuronium bromide 0.3 mg kg-1 Drug: Fentanyl Drug: Propofol Drug: Sevoflurane Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
Study Start Date : July 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.

Drug: Rocuronium bromide 0.15 mg kg-1
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 Name: Esmerone

Drug: Fentanyl
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Name: 하나구연산펜타닐주사

Drug: Propofol
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Name: Fresofol MCT 1%

Drug: Sevoflurane
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Name: 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.

Drug: Rocuronium bromide 0.3 mg kg-1
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 Name: Esmerone

Drug: Fentanyl
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Name: 하나구연산펜타닐주사

Drug: Propofol
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Name: Fresofol MCT 1%

Drug: Sevoflurane
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Name: 세보프란 흡입액

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 .
Drug: Fentanyl
Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
Other Name: 하나구연산펜타닐주사

Drug: Propofol
Propofol 2.5 mg kg-1 was injected at I.V. line to patients
Other Name: Fresofol MCT 1%

Drug: Sevoflurane
After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
Other Name: 세보프란 흡입액




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467595


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sangjae Park, Resident, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02467595     History of Changes
Other Study ID Numbers: ED14142
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sangjae Park, Korea University Anam Hospital:
no muscle relaxant
rocuronium
intubation condition
tracheal intubation
operating room time
low-dose rocuronium
Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Bromides
Anesthetics
Propofol
Sevoflurane
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Anticonvulsants