| CTRI Number |
CTRI/2024/07/069781 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| 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
|
A study to compare the routine clinical evaluation based versus nerve stimulating muscle response monitor guidance for evaluation of adequacy of muscle recovery before removal of tube from trachea and its impact on lung function after surgery in patients undergoing General anaesthesia. |
|
Scientific Title of Study
|
Comparison of standard clinical assessment based decision with Quantitative Neuromsucular monitor guidance for evaluation of the adequacy of neuromuscular recovery before tracheal extubation and Its Impact on Postoperative spirometry in Patients Undergoing General anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MV Vidya |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pondicherry institute of medical sciences Campus,Kalapet,Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9585550838 |
| Fax |
|
| Email |
drmvvidya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sivakumar S |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pondicherry institute of medical sciences Campus,Kalapet,Puducherry.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9944060676 |
| Fax |
|
| Email |
siva85dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MV Vidya |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pondicherry institute of medical sciences Campus, Kalapet, Puducherry.
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9585550838 |
| Fax |
|
| Email |
drmvvidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry institute of medical sciences Campus,Kalapet, Puducherry-605014,INDIA
|
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014. |
| Type of Sponsor |
Private medical college |
|
|
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 MV Vidya |
Pondicherry Institute of Medical Sciences |
Department of Anaesthesiology, Pondicherry institute of medical sciences Campus,
Ganapathichettikulam Village Kalapet, Puducherry-605014
Pondicherry
PONDICHERRY |
9585550838
drmvvidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE |
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 |
Acceleromyography group |
Assessment of neuromuscular function recovery using quantitative neuromuscular monitoring (numerical TOF ratio) based extubation in patients undergoing general anaesthesia with endotracheal Intubation for elective surgery. The total duration will be around 30 minutes |
| Comparator Agent |
Standard Group |
Assessment of Neuromuscular function recovery will be based on Standard conventional clinical assessment based extubation decision used at the end of surgery in Patients undergoing general anaesthesia with endotracheal Intubation for elective surgery. The total duration will be around 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiology (ASA) physical status I and II undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients with ASA status III and above,Pregnant women,Patients with history of neuromuscular diseases,on medications that interfere with neuromuscular junction function,renal, hepatic or respiratory disease,BMI greater than 35kg per m2,Pre operative hypothyroidism,undergoing brain or thoracic surgery
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Compare postoperative Forced Vital Capacity (FVC) and Peak Expiratory Flow (PEF) reductions in the immediate first hour postoperative period in patients with RNMB following the reversal strategy either using TOF monitor versus standard conventional clinical judgment.
b) Number of patients with residual NMB in both the groups and time to achieve TOF of 1.0 post extubation in PACU
|
a) PFT - Preoperatively baseline and 30 mins,1hr,1hr 30 mins, 2hrs postoperatively
b) TOF ratio - every 5 mins upto 1 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the following parameters between the 2 groups adverse respiratory events 1) Hypoxia (SpO2 less than 90%) 2) Respiratory distress RR greater than 30 3) upper airway obstruction |
2 hr |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial to compare standard clinical assessment-based decision-making with quantitative neuromuscular monitor guidance for evaluating the adequacy of neuromuscular recovery before tracheal extubation and its impact on postoperative spirometry in patients undergoing general anesthesia. The study will be conducted at the Pondicherry Institute of Medical Sciences (PIMS), a 740-bed multi-specialty hospital and teaching institute in Ganapathichettikulam, Puducherry. The primary outcome is to compare the quantitative impact of residual neuromuscular blockade (RNMB) on postoperative pulmonary function in patients undergoing elective surgery under general anesthesia with endotracheal intubation using Train of Four (TOF) monitoring versus standardized clinical assessment-based recovery of neuromuscular blockade. This includes
a) Compare postoperative Forced Vital Capacity (FVC) and Peak Expiratory Flow (PEF) reductions in the immediate first-hour postoperative period in patients with RNMB following the reversal strategy using either a TOF monitor or standard conventional clinical judgment.
b) Compare the number of patients with residual NMB in both groups and the time to achieve a TOF of 1.0 post-extubation in the Post-Anesthesia Care Unit (PACU).
The secondary outcome is to compare the following parameters between the two groups: hypoxia (SpO2 less than 90%), respiratory distress (RR > 30), and upper airway obstruction. |