CTRI Number |
CTRI/2021/10/037382 [Registered on: 20/10/2021] Trial Registered Prospectively |
Last Modified On: |
18/10/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
TO STUDY THE EFFECT OF NEUROMUSCULAR TRANSMISSION MONITORING ON THE REQUIREMENT OF MUSCLE RELAXANT AND RECOVERY IN PATIENTS UNDERGOING GENERAL ANAESTHESIA |
Scientific Title of Study
|
TO STUDY THE EFFECT OF NEUROMUSCULAR TRANSMISSION MONITORING (TOF) ON THE REQUIREMENT OF MUSCLE RELAXANT AND RECOVERY IN PATIENTS UNDERGOING GENERAL ANAESTHESIA |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Aparna Bagle |
Designation |
Professor |
Affiliation |
Professor department of anesthesiology |
Address |
Department of Anaesthesia,, Dr D Y Patil Medical College and Hospital Department of Anaesthesia,, Dr D Y Patil Medical College and Hospital Pune MAHARASHTRA 411018 India |
Phone |
9834430811 |
Fax |
|
Email |
draparnabagle@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Preeti Raj |
Designation |
Junior resident |
Affiliation |
Dr D Y Patil Hospital and Research Centre |
Address |
Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri Pune MAHARASHTRA 411018 India |
Phone |
9810749754 |
Fax |
|
Email |
hipreeti20@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Preeti Raj |
Designation |
Junior resident |
Affiliation |
Dr D Y Patil Hospital and Research Centre |
Address |
Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri Department of anaesthesia,Dr D Y Patil Hospital and research centre, Pimpri Pune MAHARASHTRA 411018 India |
Phone |
9810749754 |
Fax |
|
Email |
hipreeti20@gmail.com |
|
Source of Monetary or Material Support
|
Dr D Y Patil Hospital and Research Centre, Pune |
|
Primary Sponsor
|
Name |
Dr D Y Patil Hospital and Research Centre |
Address |
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra- 411018 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Preeti |
Department of Anaesthesia, Dr. D Y Patil Medical College and Research Centre |
Dr D Y Patil Hospital and research centre, Pimpri, Pune Pune MAHARASHTRA |
9810749754
hipreeti20@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee, Dr D Y Patil Vidyapeeth, Pune |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
TOF Monitor |
Time from the last dose of injection Vecuronium till recovery TOF ratio to 0.9 in Group A |
Comparator Agent |
Without TOF Monitor |
Time from the last dose of injection Vecuronium return of spontaneous respiration in Group B will be noted. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients undergoing general anaesthesia
Patients under ASA I and II
Age between 18 to 60 years.
Patients willing to sign the informed consent voluntarily
|
|
ExclusionCriteria |
Details |
Pregnant females
Patients with cognitive and mental disorders
Patients with any neuromuscular disorders
ASA III and above
Patients with anticipated difficult intubation
Surgery duration of more than 4 hours
Surgeries in which either major blood loss/fluid shifts expected or occurs
Surgeries of Head and neck
Planned for awake extubations
Patient in need of postsurgery intensive care admission
Patient with body mass index >35 kg/m2
Patient with hepatic disease (liver enzyme value >50% normal value)
Patient with renal insufficiency (serum creatinine>1.8 mg/dL)
Patient with history of consumption of drugs known to affect neuromuscular transmission
Any contraindications to neostigmine and/or atropine sulphate
Patient with history of hypersensitivity or allergic to anaesthetic agent given
Difficulty accessing the TOF measuring device in the ulnar nerve. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To study the effect of neuromuscular transmission monitoring (train of four) on the requirement of muscle relaxant and recovery in patients undergoing general anaesthesia |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)To determine the total dose of muscle relaxant requirement for intubation
2)To determine the dose of intra-operative muscle relaxant requirement per hour
3)To observe the time required for the patient to respond to verbal commands after stopping of all the anaesthesia maintenance drugs
4)To observe the time required for extubation
5)To observe for any postoperative residual paralysis |
5 hours |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
21/10/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hipreeti20@gmail.com].
- For how long will this data be available start date provided 01-03-2022 and end date provided 31-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
A
wide range of surgeries are done under general anaesthesia, and the maintenance
of muscle relaxation is important in facilitating surgical procedures.Neuromuscular blocking agents (NMBA),
which are used in facilitation of intubation for general anaesthesia and
maintenance of muscle relaxation during the surgery, pose risk of residual
paralysis. Residual paralysis (RP) after neuromuscular blockade (NMB) in the
recovery room occurs in around 56.5% of patients, and it can increase the
incidence of airway obstruction, hypoxaemia and postoperative pulmonary
complications.
Neuromuscular
Transmission monitoring (NMTM) is a means to determine the degree of NMB by
stimulating a motor nerve with electric
current and observe the degree of contraction of the muscles innervated by that
nerve. It is used to
evaluate the effect of NMBA. The muscle
response after stimulation of its corresponding motor nerve is assessed. The
most frequently assessed nerve-muscle unit is the ulnar nerve and the adductor
pollicis muscle.The muscle response can be evaluated either qualitatively or
quantitatively. Qualitative (subjective) assessment is done with a peripheral
nerve stimulator, where the observer evaluates the muscle response either
tactically or visually. Quantitative assessment is done with the monitor and
the response is objectively measured and displayed on a screen.Mechanomyography,
electromyography and acceleromyography are such muscle response recording
methods in quantitative monitoring. The types of stimuli used in NMTM are
single stimulus, train of four (TOF) and post tetanic count (PTC).The TOF
technique has remained the most useful method for assessing neuromuscular
function for more than 40 years because it is simple and easy to assess. It is
based on the observation that increased stimulation frequency produces muscle
fatigue or fade. The proportion that results from dividing the fourth by the
first evoked twitch (T4/T1) is the train-of-four ratio (TOFR). TOF has been
recommended in clinical practice because it is the test that measures
neuromuscular function and is capable of providing information even when no
prior value has been obtained. TOF count is an excellent guide considering that it reports not only the
degree of neuromuscular block but also the state of recovery from it. In most of the centers, the subjective assessment of
recovery from the effect of a NMBA is done by observing eye‑opening,
tongue protrusion, head lift and sustained hand grip for more than 5 seconds.
Our study would
like to evaluate the efficiency of the use of objective neuromuscular
transmission monitoring by TOF when compared to subjective assessment in
guiding the frequency of repeating the NMBAs during surgery and in assessing
adequacy of reversal from NMBA at the time of recovery from generalanaesthesia
and in incidences of postoperative residual paralysis. |