| CTRI Number |
CTRI/2024/09/074341 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of Residual Neuromuscular Blockade in the Post Anaesthesia Care Unit |
|
Scientific Title of Study
|
Incidence of Residual Neuromuscular Blockade in the Postanaesthesia Care Unit: An Observational Study. |
| 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 Savitar Malhotra |
| Designation |
Senior Consultant |
| Affiliation |
Institute of Anaesthesiology Pain and Perioperative Medicine |
| Address |
Room No 10, 5th floor, SSRB Block, Sir Ganga Ram Hospital Rajinder Nagar New Delhi-110060
Central
DELHI
110060
India |
| Phone |
9958908713 |
| Fax |
|
| Email |
savitarmalhotra@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Renu Dahiya |
| Designation |
DNB Trainee |
| Affiliation |
Institute of Anaesthesiology Pain and Perioperative Medicine |
| Address |
Room No 10 5th Floor, SSRB Block, Sir Ganga Ram Hospital Rajinder Nagar New Delhi-110060
Central
DELHI
110060
India |
| Phone |
9416648685 |
| Fax |
|
| Email |
rrenudahiya2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savitar Malhotra |
| Designation |
Senior Consultant |
| Affiliation |
Institute of Anaesthesiology Pain and Perioperative Medicine |
| Address |
Room No 10 5th Floor, SSRB Block, Sir Ganga Ram Hospital Rajinder Nagar New Delhi-110060
DELHI
110060
India |
| Phone |
9958908713 |
| Fax |
|
| Email |
savitarmalhotra@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital Rajinder Nagar New Delhi-110060 INDIA |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Rajinder Nagar,New Delhi-110060 |
| 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 Savitar Malhotra |
Sir Ganga Ram Hospital, Rajinder Nagar |
Room No 10, 5th floor, SSRB Block, Institute of Anaesthesiology, Pain & Perioperative Medicine, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi-110060
Central
DELHI |
9958908713
savitarmalhotra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical classification I to II
2. Patients undergoing lower abdominal surgery, general, urological, or gynaecologic
surgery under general anaesthesia with neuromuscular blockade. |
|
| ExclusionCriteria |
| Details |
1. Patients not consenting.
2. Patients with known neuromuscular disorders (e.g. myasthenia gravis)
3. Patients undergoing organ transplant surgery, open upper abdominal surgery, emergency
procedures, and patients needing intensive care admission in the post-operative period.
4. Patient undergoing thoracic surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients having neuromuscular blockade TOF ratio less than 0.9. |
10 mins after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Fall of SpO2 less than 95 % on oxygen support.
b. Duration of stay in PACU.
c. Need of airway support (viz. airway opening manoeuvres, oral or nasal airway,
CPAP / BiPAP, endotracheal intubation) |
10 mins after extubation |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
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)
|
10/10/2024 |
| 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="0"
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
|
Residual neuromuscular blockade is a known cause of postoperative complications after general anaesthesia with relaxants. Various reasons have been cited for this, including but not limited to the type of surgery, duration of surgery, neuromuscular blocker used, dose of Neuromuscular blockade and the type and dose of reversal used. Many measures have been suggested to reduce the incidence of Residual neuromuscular blockade, like adequate titration of dose of Neuromuscular blockade and reversal used and timing of the reversal agent, to preclude Residual neuromuscular blockade but various studies continue to show significant incidence of Residual Neuromuscular blockade and its associated morbidity. Neuromuscular monitoring is a useful tool, both intraoperatively and postoperatively to guide Neuromuscular blockade use and reversal but is not used often and to its potential. It can significantly reduce the incidences of Residual neuromuscular blockade. We aim to conduct an observational study into the incidence of Residual neuromuscular blockade in the post anaesthesia care unit of patients undergoing surgery in general anaesthesia with muscle relaxants. This study will include 290 Patients. All patients found eligible and who consent to the study will be enrolled. Demographic and clinical details of the patients will be noted. All patients undergoing surgery under general anaesthesia, will be checked for Residual neuromuscular blockade with a neuromuscular monitor using Train of four mode, on their arrival to the Post anaesthesia care unit. Patients having a TOF ratio < 0.9 will be considered to have a Residual neuromuscular blockade. |