| CTRI Number |
CTRI/2025/12/099074 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of nebulisation with the sedative drug dexmedetomidine on heart rate and blood pressure changes during laryngoscopy and tracheal intubation with breathing tube in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
A randomised clinical trial on the effect of nebulised dexmedetomidine on hemodynamic response to laryngoscopy and intubation in patients undergoing surgery under general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M KONOM PHOM |
| Designation |
Post graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences Imphal West Manipur India |
| Address |
Regional Institute of Medical Sciences Imphal West Manipur India
Imphal West MANIPUR 795004 India |
| Phone |
9863734637 |
| Fax |
|
| Email |
konomphom98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
N Ratan Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal West Manipur India |
| Address |
Regional Institute of Medical Sciences Imphal West Manipur India
Imphal West MANIPUR 795004 India |
| Phone |
9436027270 |
| Fax |
|
| Email |
nratansingh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
N Ratan Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal West Manipur India |
| Address |
Regional Institute of Medical Sciences Imphal West Manipur India
Imphal West MANIPUR 795004 India |
| Phone |
9436027270 |
| Fax |
|
| Email |
nratansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West Manipur India 795004 |
|
|
Primary Sponsor
|
| Name |
M Konom Phom |
| Address |
Regional Institute of Medical Sciences Imphal West Manipur India Pin code 795004 |
| Type of Sponsor |
Other [Post graduate trainee] |
|
|
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 M Konom Phom |
Regional Institute of Medical Sciences Imphal Manipur |
All operation theatres of Regional Institute of Medical Sciences Imphal West Manipur India Imphal West MANIPUR |
9863734637
konomphom98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board Regional Institute of Medical Sciences Imphal Manipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine hydrochloride injection |
Consenting participants will receive nebulization with 0.5mcg per kg of dexmedetomidine diluted with normal saline to a volume of 5 ml till all the drug is aerosolized thirty minutes before induction of general anaesthesia and hemodynamic parameters like heart rate and BP will be measured at different time points up to ten minutes after endotracheal intubation |
| Comparator Agent |
Normal saline 0.9 percent |
Consenting patients will be randomly allocated into two groups. Study participants will receive nebulization with 5ml of normal saline thirty minutes before induction of general anaesthesia and hemodynamic parameters like heart rate and BP will be measured at different time points up to ten minutes after endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group 18 to 60 years of either gender
2.Patients of American Society of Anaesthesiologists physical grade I or II |
|
| ExclusionCriteria |
| Details |
1.Patients on medications that affect heart rate
2.Patients with uncontrolled hypertension or hypotension
3.Obese patients with BMI more than 30 kg per metre square
4.Allergy to study drug
5.Emergency surgeries or anticipated difficult airway
6.Patients with renal failure or known cardiovascular or neurosurgical pathology
7.Pregnant or lactating patients
History of recent upper respiratory tract infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters (Heart rate, systolic and diastolic blood pressure and mean arterial pressure) |
Baseline, during intubation, one minute, three minutes, five minutes, seven minutes and ten minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
24/12/2025 |
| 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="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 Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 (Others) - Access will be restricted to the investigator and the supervisor, and the REB members on demand. The findings of the study based on the collective data will be published without identifying the individual.
- For how long will this data be available start date provided 12-12-2027 and end date provided 12-12-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study will be conducted on, “The effect of nebulised Dexmedetomidine on hemodynamic response to laryngoscopy and intubation in patients undergoing surgery under general anaesthesia. A Randomised Clinical Trial. Here in our study, patients will be randomly allocated into two groups using a computer-generated block randomization sequence. A total of 52 ASA grade 1 or 2 patients, aged 18–60 years, of either gender, will be randomly allocated into two groups. Patients allocated into Group D will receive nebulized dexmedetomidine (0.5mcg per kg) and Group N will receive nebulized normal saline. The study drug will be prepared by an anaesthesiologist not directly involved in the study, as a uniform 5 ml solution. Allocation concealment will be ensured using sequentially numbered opaque sealed envelopes. The study drug will be administered as aerosol using an electric compressor nebulizer in a propped up or semi recumbent position 30 minutes before induction of general anaesthesia. Nebulization will be done with a 200 cm tubing connected from the oxygen port (100 percent oxygen at a flow rate of 10L per min) attached with a nebulisation mask. Nebulization will continue until the entire solution in the nebulizer gets aerosolized (10 to 15 mins). The anaesthetist blinded to the study will record the following parameters, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and SpO2, at the following time points, at baseline (before nebulization), after nebulization but before induction, during laryngoscopy and intubation, at 1 minute, 3 minutes, 5 minutes, 7 minutes and 10 minutes post-intubation. The observations made during the study will be tabulated, graphically depicted whenever possible, statistically analysed and inferences will be drawn to study the effect of airway nebulization with dexmedetomidine (0.5 mcg per kg) on stress response to laryngoscopy and intubation. |