| CTRI Number |
CTRI/2025/07/091302 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how muscle relaxant medicines affect breathing support through a face mask during general anaesthesia |
|
Scientific Title of Study
|
Comparison of face mask ventilation before and after neuromuscular blockade in patients under 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 |
Nurya Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi |
| Address |
Room no. 301 third floor Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9501104324 |
| Fax |
|
| Email |
noor22gupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Singh |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital,New Delhi |
| Address |
Room no.301 third floor Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9910241887 |
| Fax |
|
| Email |
drjyoti.md@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no.301 third floor Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9711936946 |
| Fax |
|
| Email |
yadavnids@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr.Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib ,Connaught Place, New Delhi 110001 New Delhi |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi 110001 |
| Type of Sponsor |
Government 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 Nurya Gupta |
ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi |
Room no.301 Department of Anaesthesia ABVIMS and Dr.RML Hospital, New Delhi 110001
New Delhi
DELHI |
9501104324
noor22gupta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr. RML Hospital , New Delhi |
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
Modification(s)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgical procedure under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Pregnant females
2. Patients with BMI more than 30 kg per meter square
3. Anticipated difficult face mask ventilation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expiratory tidal volume |
Expiratory tidal volume before and after neuromuscular blockade at 1minute,2 minute,3 minute and 4 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Han scale grade of face mask ventilation |
Han scale grade of face mask ventilation before and after neuromuscular blockade at baseline |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="5"
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 aims to compare face mask ventilation before and after giving a muscle relaxant in adult patients under general anaesthesia. All patients will be assessed before surgery with a medical history clinical examination and relevant investigations. Demographic data such as age ,sex, height ,weight and American Society of Anaesthesiologiats status will be recorded. Patients who are pregnant under 18 years old ,have a Body Mass Index over 30 or have anticipated difficulty with face mask ventilation will be excluded.
In the operating room standard monitoring including Electrocardiogram,Non invasive blood pressure and Saturation prbe will be applied and patients will be positioned supine with their head in a sniffing position. Premedication with intravenous Midazolam 1 milligram and Fentanyl 2 microgram per kilogtam will be administered. After preoxygenation anaesthesia will be induced with intravenous Propofol 2 milligram per kg .Face mask ventilation will be performed using a standard technique and ventilator settings of inspiratory pressure 10 centimeter of water, Positive end expiratory pressure of 5 centimeter of water, Inspiratory to Expiratory ratio 1 to 2 ,gas flow 6 litres per minute .respiratory rate 12 per minute and Sevoflurane 2 to 3 percent in 100 percent oxygen. Expired tidal volumes and Han scale grading for face mask ventilation will be recorded
One minute later intravenous Vecuronium 0.1 milligram per kg will be administered and face mask ventilation will be reassessed at 1minute ,2 minute, 3minute and 4 minutes after its administration. The primary objective is to evaluate changes in face mask ventilation before and after the neuromuscular blockade. |