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

Primary Purpose

Muscle Relaxant, General Anesthesia

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Dose of Neostigmine
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Relaxant

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo Cental National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

partial dose of neostigmine

TOF ratio-based dose of neostigmine

Arm Description

Those who received partial dose of neostigmine as rocuronium reversal

Those who received TOF ratio-based dose of neostigmine as rocuronium reversal

Outcomes

Primary Outcome Measures

TOF ratio with partial dose of neostigmine
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
TOF ratio with TOF ratio-based dose of neostigmine
TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine
time needed to reach TOF ratio ≥ 90% in group with partial dose of neostigmine

Secondary Outcome Measures

Full Information

First Posted
February 12, 2017
Last Updated
August 15, 2017
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03058263
Brief Title
Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Relaxant, General Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
partial dose of neostigmine
Arm Type
Experimental
Arm Description
Those who received partial dose of neostigmine as rocuronium reversal
Arm Title
TOF ratio-based dose of neostigmine
Arm Type
Experimental
Arm Description
Those who received TOF ratio-based dose of neostigmine as rocuronium reversal
Intervention Type
Drug
Intervention Name(s)
Dose of Neostigmine
Other Intervention Name(s)
prostigmin
Intervention Description
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
Primary Outcome Measure Information:
Title
TOF ratio with partial dose of neostigmine
Description
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
Time Frame
Day 1
Title
TOF ratio with TOF ratio-based dose of neostigmine
Time Frame
Day 1
Title
TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine
Time Frame
Day 1
Title
time needed to reach TOF ratio ≥ 90% in group with partial dose of neostigmine
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arif HM Marsaban, Consultant
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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URL
http://www.apsf.org/newsletters/pdf/Feb2016final_lores.pdf
Description
Van Pelt M, Chitilian HV, Eikerman M. Multi-faceted initiative designed to improve safety of neuromuscular blockade. APSF. 2016; 30: 45-76

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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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