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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035102
Receipt No. R000040013
Official scientific title of the study OPTIMALISATION OF REVERSAL CLINICAL STRATEGY WITHOUT TOF MONITORING IS EQUIVALENT TO REVERSAL CLINICAL STRATEGY USING QUANTITATIVE TOF MONITORING? COMPARISON STUDY ON INCIDENCE OF RESIDUAL PARALYSIS AT RECOVERY ROOM FOR PATIENTS RECEIVING ROCURONIUM AND SEVOFLURANE
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/01

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Basic information
Official scientific title of the study OPTIMALISATION OF REVERSAL CLINICAL STRATEGY WITHOUT TOF MONITORING IS EQUIVALENT TO REVERSAL CLINICAL STRATEGY USING QUANTITATIVE TOF MONITORING?
COMPARISON STUDY ON INCIDENCE OF RESIDUAL PARALYSIS AT RECOVERY ROOM FOR PATIENTS RECEIVING ROCURONIUM AND SEVOFLURANE
Title of the study (Brief title) OPTIMIZED REVERSAL WITHOUT TOF MONITORING VERSUS REVERSAL USING QUANTITATIVE TOF MONITORING:
AN EQUIVALENCE STUDY
Region
Asia(except Japan)

Condition
Condition Intubated patients under general anesthesia using sevoflurane and rocuronium
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Optimizing neostigmine reversal strategy has never been studied. Therefore, the authors would like to see whether optimization of neostigmine reversal clinical strategy without TOF monitoring is equivalent to neostigmine reversal strategy using TOF monitoring. From this study, the authors may provide recommendations to clinicians who have limitations in the availability of peripheral nerve stimulation device and sugammadex.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the proportion of subjects who have residual paralysis in the recovery room based on the threshold value <0.90
Key secondary outcomes the proportion of subjects who have airway problems, respiration patterns, oxygen saturation, nausea and vomiting during 30 minutes in the recovery room

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 For subjects in group A (without TOF monitoring), the first researcher counted the time since last rocuronium administration and assessed the subject's spontaneous breathing effort. Neostigmine dosing followed the protocol below:
a. Neostigmine was administered if the spontaneous breathing has been detected or the time since last rocuronium administration has exceeded 30 minutes.
b. The dose of neostigmine was based on the estimated depth of blockade:
The time since last rocuronium administration > 30 minutes, without evidence of spontaneous breathing effort: 50 mcg/kg and atropine sulfate 10 mcg/kg.
Minimal spontaneous breathing, and the time since last rocuronium administration <30 minutes: 30-40 mcg/kg and atropine sulfate 10 mcg/kg.
Minimal spontaneous breathing, and the time since last rocuronium administration > 30 minutes: 20-30 mcg/kg and atropine sulfate 10 mcg/kg.
Sufficient spontaneous breathing pattern: 10 mcg/kg and atropine sulfate 10 mcg/kg.

Extubation was carried out in group A at least 15 minutes after reversal attempt.
Interventions/Control_2 For subjects in the group with TOF monitoring (group B), TOF stimulation was given without calibration with a stimulation of 50 mA. Measurements were carried out in 12 second cycle mode. Neostigmine was given at a dose according to the measured TOF value at the start of skin / muscle closure, as followed:
TOF 0-1 (intense block): delay giving neostigmine.
TOF 2-4 (moderate block): Neostigmine 50 mcg/kg and atropine sulfate 10 mcg/kg.
TOF ratio <=0.40 (mild block): Neostigmine 40 mcg/kg and atropine sulfate 10 mcg/kg.
TOF ratio 0.40-0.70 (minimal block): Neostigmine 20-30 mcg/kg and atropine sulfate 10 mcg/kg.
TOF ratio 0.70-0.90 (minimal block): Neostigmine 10 mcg/kg and atropine sulfate 10 mcg/kg
TOF ratio value >= 0.90 (fully recovered): Neostigmine should not be given.

After the surgical procedure was complete and the TOF ratio >=0.90 in group B, the TOF device was detached and the subject was extubated.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria patients aged 18-60 years, with ASA 1-2 physical status who will undergo elective non-head/neck surgery below general anesthesia procedure intubation
Key exclusion criteria elective surgery <1 hour duration; awake extubation or post-surgery intensive care admission; body mass index> 35 kg/m2; had hepatic disease (liver enzyme value> 50% normal value); renal insufficiency (serum creatinine>1.8 mg/dL), neuromuscular disease; consumption of drugs known to affect neuromuscular transmission; contraindications to neostigmine and or atropine sulfate; a history of hypersensitivity or allergic to neostigmine, rocuronium or anesthetic agent given; difficulty accessing the TOF measuring device in the ulnar nerve.
Target sample size 80

Research contact person
Name of lead principal investigator Ardyan Prima Wardhana
Organization FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY
Division name DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY
Address FARMAKO SEKIP UTARA, YOGYAKARTA, INDONESIA, 55281
TEL 6282138433032
Email ardyan.wardhana@yahoo.com

Public contact
Name of contact person Ardyan Prima Wardhana
Organization FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY
Division name DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY
Address FARMAKO SEKIP UTARA, YOGYAKARTA, INDONESIA, 55281
TEL 6282138433032
Homepage URL
Email ardyan.wardhana@yahoo.com

Sponsor
Institute RSUP Dr. Sardjito Yogyakarta
Institute
Department

Funding Source
Organization RSUP Dr. Sardjito Yogyakarta
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 01 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
2018 Year 07 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 10 Day
Date analysis concluded
2018 Year 09 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results Six (16.7%) residual paralysis in the recovery room occurred in group A, while one case (2.8%) occurred in group B (p=0.107; 95%CI 0.01; 0.27). No subjects had TOF ratio <0.70 in the recovery room. The TOF ratio in the recovery room did not differ between two groups (p=0.053; 95%CI -5.20; 0.29). However, the reversal-extubation time in group A was longer than in group B. The absolute difference in the proportion of residual paralysis in the recovery room was 13.9% (95%CI 6%; 27.2%). The equivalence test showed that the 95% confidence interval of this study is partly outside the range of equivalence margin (15%). One respiratory adverse event in the recovery room was found in this study.
Other related information

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040013

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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