| CTRI Number |
CTRI/2026/01/101935 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anaylsis of hemodynamic responses during tracheal intubation by neuromuscular block monitored versus clinical assessment guided tracheal intubation |
|
Scientific Title of Study
|
A comparative analysis of hemodynamic responses during clinical assessment guided tracheal intubation versus neuromuscular block monitoring guided tracheal intubation a prospective randomized interventional 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 |
Neelu Panghal |
| Designation |
Post graduate resident |
| Affiliation |
Department of Anaesthesiology Maharaja Agrasen Medical college Agroha Hisar Haryana |
| Address |
Department of Anaesthesiology Maharaja Agrasen Medical College, Agroha Hisar Haryana
Room no 213 Dharamshala community center Girls hostel maharaja Agrasen medical college, Agroha Hisar Haryana
Hisar
HARYANA
125047
India |
| Phone |
8708681193 |
| Fax |
|
| Email |
neelupanghal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Maharaja Agrasen Medical College, Agroha Hisar |
| Address |
Department of Anaesthesiology Maharaja Agrasen Medical College, Agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
8307994393 |
| Fax |
|
| Email |
drsumitrakanojiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra |
| Designation |
Professor Department of Anaesthesiology |
| Affiliation |
Maharaja Agrasen Medical College, Agroha Hisar |
| Address |
Department of Anaesthesiology Maharaja Agrasen Medical College, Agroha Hisar
Hisar
HARYANA
125047
India |
| Phone |
8307994393 |
| Fax |
|
| Email |
drsumitrakanojiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Maharaja Agrasen Medical College Agroha Hisar Haryana India pincode 125047 |
|
|
Primary Sponsor
|
| Name |
Dr Neelu Panghal |
| Address |
Department of Anaesthesiology Maharaja Agrasen Medical College, Agroha Hisar Haryana India pincode 125047 |
| 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 Neelu Panghal |
Maharaja Agrasen Medical College Agroha Hisar Haryana |
Room no 120 Department of Anaesthesiology, Maharaja Agrasen Medical College Agroha Hisar Haryana pincode 125047
Hisar
HARYANA |
8708681193
neelupanghal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research mamc agroha |
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 |
| Comparator Agent |
Clinically assessment guided tracheal intubation |
Hemodynamic changes while intubation at T0 baseline, immediately after intubation T1, 1 min after induction T2, after cuff inflation following intubation T3, 1min, 3min, 5min after intubation T4,5,6 |
| Intervention |
Neuromuscular block monitoring guided intubation |
Hemodynamic changes while intubation at T0 baseline, immediately after intubation T1, 1 min after induction T2, after cuff inflation following intubation T3, 1min, 3min, 5min after intubation T4,5,6 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with either sex, 18-60 years , American Society Of Anaesthesiology (ASA) Physical Status class I and II willing to participate in study |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to give consent
2. Obesity BMI more than 30kg/m2
3. Patient allergic to study drugs
4. Pregnant
5. Known neuromuscular diseases
6. Hepatic or renal dysfunction
7. Anticipated difficult airway Mallampati III or IV
8. Limited mouth opening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure hemodynamic changes Heart rate, mean arterial pressure, systolic and diastolic blood pressure |
at T0 baseline, immediately after intubation T1, 1 min after induction T2, after cuff inflation following intubation T3, 1min, 3min, 5min after intubation T4,5,6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intubating Condition
Time to optimal intubation Condition
Number of intubation attempts
Postoperative complications |
at T0 baseline, immediately after intubation T1, 1 min after induction T2, after cuff inflation following intubation T3, 1min, 3min, 5min after intubation T4,5,6 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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 - 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 - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [neelupanghal@gmail.com ].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2027?
Response (Others) - Immediately following publication. No end date
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Th present study will be randomized, parallel group single blind trial and will be conducted at department of Anaesthesiology and Critical Care at Maharaja Agrasen Medical College Agroha Hisar after approval from IEC. There will be 2 groups group C (clinical assessment guided intubation) and group NM (neuromuscular monitoring guided intubation) . The study primary outcome will be to compare the hemodynamic responses in both groups and secondary outcome will be to compare the intubating conditions , time to optimal intubating conditions , number of intubation attempts , post operative conditions in both the groups. |