| CTRI Number |
CTRI/2025/07/091853 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Inhaled Dexmedetomidine with Inhaled Fentanyl for Treating Headache After Spinal Anaesthesia |
|
Scientific Title of Study
|
Nebulised Dexmedetomidine Versus Nebulised Fentanyl for the
Treatment of Post-Dural Puncture Headache (PDPH) Following Spinal Anaesthesia: A
Randomised Controlled Trial |
| 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 KESHAVI BHARADWAJ |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
9711878236 |
| Fax |
|
| Email |
keshavibharadwaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KESHAVI BHARADWAJ |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR
800014
India |
| Phone |
9711878236 |
| Fax |
|
| Email |
keshavibharadwaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BIBHA KUMARI |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology. Indira Gandhi Institute of Medical Sciences, Patna
Patna
BIHAR
800014
India |
| Phone |
8252410069 |
| Fax |
|
| Email |
drbibha98aditi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, 1ST floor ward block,Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India 800014 |
|
|
Primary Sponsor
|
| Name |
DR KESHAVI BHARADWAJ |
| Address |
Department of Anesthesiology, 1ST floor ward block,Indira Gandhi Institute of Medical Sciences, Patna, Bihar, India 800014 |
| Type of Sponsor |
Other [Self] |
|
|
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 Keshavi Bharadwaj |
Indira Gandhi Institute of Medical Sciences Patna |
Department of Anesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna
Patna
BIHAR |
9711878236
keshavibharadwaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna |
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 |
Nebulised Dexmedetomidine |
Patients in Group D will receive nebulised dexmedetomidine 1 mcg/kg (4ml) every 12 hours for the first 72 hours in a semi-recumbent position using a nebuliser. |
| Comparator Agent |
Nebulised Fentanyl |
Patients in group F will receive nebulised fentanyl 1mcg/kg (4ml) every 12 hours for the first 72 hours post spinal anesthesia in a semi-recumbent position using a nebuliser. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate
2. Patients of physical status I/II according to American Society of Anaesthesiologists Grading
3. Patients developing PDPH post lower abdominal and lower limb surgeries under spinal anaesthesia within 72 hours
4. Patients qualifying for the criteria of PDPH (with headache severity score more than 4) as laid down by the International Headache Society |
|
| ExclusionCriteria |
| Details |
1. Patients having history of allergy to the study drug
2. Patients with body mass index less than 25kg/m2
3. Patient with history of migraine or other types of headache, on chronic treatment of headache
4. Patients with hemodynamic instability or bradyarrythmias |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the severity of headache after 24 hours of 1st nebulisation |
24 hours post 1st nebulisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence rate of PDPH at tertiary care centre, calculate the number of patients requiring additional analgesics, asses any adverse effects (hypotension, bradycardia, oxygen desaturation, dry
mouth, sneezing and coughing) – during and after nebulisation, compare the analgesic effect of nebulised dexmedetomidine to fentanyl using VAS score |
At 0, 12, 24, 36, 48 and 72 hours of nebulisation |
|
|
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)
|
25/08/2025 |
| 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 Yet Recruiting |
| 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [keshavibharadwaj@gmail.com].
- For how long will this data be available start date provided 24-07-2026 and end date provided 23-07-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
In this randomized controlled trial 80 patients meeting the inclusion criteria will be enrolled after obtaining written informed consent and randomized into two groups (Group D and Group F), each consisting of 40 patients, using online randomisation software (Open Epi Software Version 3.01). Random allocation will be stored in sequentially numbered opaque sealed envelopes, opened just before the intervention. Group D will receive nebulised Dexmedetomidine 1 mcg/kg (4 ml), and Group F will receive nebulised Fentanyl 1 mcg/kg (4 ml). Nebulisation will be administered every 12 hours for 72 hours post spinal anaesthesia in a semi-recumbent position using a nebuliser. Baseline vitals will be recorded using a monitor. Pain will be assessed using the Numerical Rating Scale (NRS) before and after each nebulisation and at 24 hours after the first session. The requirement of additional analgesics and adverse drug effects will be noted. |