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Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose

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ClinicalTrials.gov Identifier: NCT03058263
Recruitment Status : Completed
First Posted : February 20, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Arif H. M. Marsaban, Indonesia University

Brief Summary:
This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular blockade of rocuronium

Condition or disease Intervention/treatment Phase
Muscle Relaxant General Anesthesia Drug: Dose of Neostigmine Phase 1 Phase 2

Detailed Description:
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. After preoxygenation was given with 100% oxygen, general anesthesia induction was done with midazolam 0.01-0.02 mg/kg, fentanyl 3 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Following induction, endotracheal intubation or laryngeal mask insertion was performed. Maintenance was done by sevoflurane 1.2 vol%, and fentanyl 1.2 mcg/kg. After the surgery had finished, fentanyl drip was stopped. Subjects were then observed until spontaneous breaths occured adequately (tidal volume ≥ 5 ml/kg) before train of four (TOF) ratio was evaluated using acceleromyography (AMG). Before reversal (neostigmine) was given, anesthetic gas was stopped and duration of operation as well as post-operative TOF ratio was recorded. The time since reversal was given then recorded. Group A received neostigmine partial dose (0.02 mg) in combination with atropine 0.4 mg for every milligram of neostigmine. Group B received TOF ratio-based dose of neostigmine in combination with atropine 0.4 mg for every milligram of neostigmine. After administration of neostigmine, TOF ratio was measured every 5 minutes until TOF ratio of ≥ 90% was achieved, and finally definitive airway could be removed. For Group A, another partial dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. For Group B, another TOF ratio-based dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. Subjects were then transported to recovery room. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Neostigmine on the Recovery of Rocuronium-Induced Neuromuscular Blockade: A Comparison Between Partial Dose and TOF Ratio-Based Adjustment Dose
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: partial dose of neostigmine
Those who received partial dose of neostigmine as rocuronium reversal
Drug: Dose of Neostigmine
Subjects were given partial dose of neostigmine as rocuronium reversal after the surgery had finished; subjects were given TOF ratio-based dose of neostigmine after the surgery had finished
Other Name: prostigmin

Experimental: TOF ratio-based dose of neostigmine
Those who received TOF ratio-based dose of neostigmine as rocuronium reversal
Drug: Dose of Neostigmine
Subjects were given partial dose of neostigmine as rocuronium reversal after the surgery had finished; subjects were given TOF ratio-based dose of neostigmine after the surgery had finished
Other Name: prostigmin




Primary Outcome Measures :
  1. TOF ratio with partial dose of neostigmine [ Time Frame: Day 1 ]
    Train-of-Four ratio obtained from post-operative acceleromyography after the first partial dose of neostigmine had been administrated until definitive airway device can be removed

  2. TOF ratio with TOF ratio-based dose of neostigmine [ Time Frame: Day 1 ]
  3. TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine [ Time Frame: Day 1 ]
  4. time needed to reach TOF ratio ≥ 90% in group with partial dose of neostigmine [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients aged 18-60 years old
  • American Society of Anesthesiologists (ASA) physical status I-II who were planned to undergo any elective surgery at operating room in general anesthesia
  • subjects had been explained about the study, and agreed to enroll and have signed the informed consent form

Exclusion Criteria:

  • BMI ≥ 30
  • had any severe kidney or liver disease
  • had neuromuscular disease or asthma

Drop out Criteria:

  • Duration of operation less than one hour or more than 2 hours
  • during surgery received maintenance dose of neuromuscular block
  • intraoperative cardiac arrest was occurred

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): NCT03058263


Locations
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Indonesia
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Arif HM Marsaban, Consultant Indonesia University

Additional Information:
Publications:

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Responsible Party: Arif H. M. Marsaban, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03058263     History of Changes
Other Study ID Numbers: IndonesiaUAnes011
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Muscle Hypotonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents