UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035102 |
|---|---|
| Receipt number | R000040013 |
| Scientific Title | 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 23:52:25 |
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Basic information
Public title
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
Acronym
OPTIMIZED REVERSAL WITHOUT TOF MONITORING VERSUS REVERSAL USING QUANTITATIVE TOF MONITORING:
AN EQUIVALENCE STUDY
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ardyan Prima Wardhana |
Organization
FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY
Division name
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY
Zip code
Address
FARMAKO SEKIP UTARA, YOGYAKARTA, INDONESIA, 55281
TEL
6282138433032
ardyan.wardhana@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ardyan Prima Wardhana |
Organization
FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY
Division name
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY
Zip code
Address
FARMAKO SEKIP UTARA, YOGYAKARTA, INDONESIA, 55281
TEL
6282138433032
Homepage URL
ardyan.wardhana@yahoo.com
Sponsor or person
Institute
RSUP Dr. Sardjito Yogyakarta
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040013
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