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Optimal Dose of Combination of Rocuronium and Cisatracurium (CRC)

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ClinicalTrials.gov Identifier: NCT02495038
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : December 20, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Wooyoung Park, Yonsei University

Brief Summary:

BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The investigators studied whether the prediction is possible to have a sufficient effect of reducing the dose when combining the two neuromuscular blocking agents through monitoring neuromuscular relaxation during surgery.

METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose (ED)95 rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each study drug was administrated to the patient and timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the ulnar nerve was used as setting of 2 Hz per 12 sec. The investigators checked time to TOF ratio=0 (Onset), time to 1st TOF ratio>25% (Duration 25%) and TOF 25-75% (recovery index) under total i.v. anesthesia (TIVA). One way ANOVA was used for statistical analysis (α=0.05, β=0.2).


Condition or disease Intervention/treatment Phase
Chronic Otitis Media Anesthesia Drug: 10% reduction of combination of Esmeron® and Nimbex® Drug: 20% reduction of combination of Esmeron® and Nimbex® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Dose of Combination of Rocuronium and Cisatracurium: A Randomized Double-blinded Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Intubating dose, Group I

combined ED95 rocuronium and ED95 cisatracurium

ED95, dose causing on average 95% suppression of neuromuscular response.

Experimental: 10% reduction of combination of Esmeron® and Nimbex®, Group S
This arm reduced 10% of combined ED95 rocuronium and ED95 cisatracurium
Drug: 10% reduction of combination of Esmeron® and Nimbex®
Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
Other Names:
  • Esmeron®, 74119419, ATC code:M03AC09
  • Nimbex®, 74500213, ATC code:M03AC11

Experimental: 20% reduction of combination of Esmeron® and Nimbex®, Group L
This arm reduced 20% of combined ED95 rocuronium and ED95 cisatracurium
Drug: 20% reduction of combination of Esmeron® and Nimbex®
The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
Other Names:
  • Esmeron®, 74119419, ATC code:M03AC09
  • Nimbex®, 74500213, ATC code:M03AC11




Primary Outcome Measures :
  1. Onset of Neuromuscular Blocking Agents(NMBAs) [ Time Frame: Intraoperative, an average of 5 minutes ]
    Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia.

  2. Duration 25% of Neuromuscular Blocking Agents(NMBAs) [ Time Frame: Intraoperative, an average of 1 hours ]
    Time from administration of initial NMBAs to Train-of-four (TOF) ratio >25%, assessed up to 2 hours during general anesthesia.

  3. Recovery Index of Neuromuscular Blocking Agents(NMBAs) [ Time Frame: Intraoperative, an average of 20 minutes ]
    Time from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia.


Secondary Outcome Measures :
  1. Operation Time [ Time Frame: Intraoperative, an average of 3 hours. ]
    Time from skin incision to wound dressing assessed up to 8 hours.

  2. Anesthetic Time [ Time Frame: Intraoperative, an average 4 hours. ]
    Time from induction to recovery of anesthesia, asessed up to 3 hours.

  3. Additional Rescue Doses Per Hour Ratio. [ Time Frame: Intraoperative, an average of 3 hours. ]
    Additional Rescue Doses Per Hour Ratio is the number per hour of addition of rescue dose administrated with 10% of initial NMBAs dose. The formula is {(Addition number + 1 / Anesthetic time) x 60}.


Other Outcome Measures:
  1. Non Invasive Blood Pressure, [ Time Frame: Before and after induction of anesthesia, an average 10 min. ]

    Before induction of anesthesia, non invasive blood pressure was measured for baseline.

    And after injection of NMBAs, non invasive blood pressure was measured at 10 min.


  2. Peripheral Oxygen Saturation [ Time Frame: Before and after induction of anesthesia, an average 10 min. ]

    Before induction of anesthesia, peripheral oxygen saturation was measured for baseline.

    And after injection of NMBAs, peripheral oxygen saturation was measured at 10 min.


  3. Body Temperature [ Time Frame: Before and after induction of anesthesia, an average 10 min. ]

    Before induction of anesthesia, body temperature was measured for baseline by oral temperature probe.

    And after injection of NMBAs, non invasive blood pressure was measured at 10 min by esophageal temperature probe.


  4. Bispectral Index [ Time Frame: Before and after induction of anesthesia, an average 10 min. ]

    The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer.

    Before induction of anesthesia, bispectral index was measured for baseline. And after injection of NMBAs, bispectral index was measured at 10 min.




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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • the American Society of Anesthesiologists (ASA) physical status I-II
  • BMI 20-30 kg/m2
  • Patients scheduled for mastoidectomy and tympanoplasty.

Exclusion Criteria:

  • a history of allergy to the study drugs,
  • neuromuscular disease,
  • pregnancy
  • breast-feeding,
  • preoperative medication of antipsychotics or neuroleptics known to interact with NMBAs
  • serum creatinine level>1.2 mg/dL,
  • liver transaminase>40 U/L.

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): NCT02495038


Sponsors and Collaborators
Yonsei University
Investigators
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Study Director: Young Gwan Cheon Institutional Review Board of Wonju Severance Christian Hospital
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wooyoung Park, clinical assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02495038    
Other Study ID Numbers: combination P-1
First Posted: July 13, 2015    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: March 2, 2018
Last Verified: January 2018
Keywords provided by Wooyoung Park, Yonsei University:
combination
rocuronium
cisatracurium
neuromuscular blockade monitoring
drug synergism
Additional relevant MeSH terms:
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Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Rocuronium
Atracurium
Cisatracurium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action