| CTRI Number |
CTRI/2025/01/079534 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of nebulization with Dexmedetomidine for headache after anaesthesia given by back injection |
|
Scientific Title of Study
|
Effectivenes of nebulized Dexmedetomidine for treatment of post dural puncture headache undergoing elective surgeries under spinal anaesthesia: a randomized controlled 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 |
RESHMA THANKAM ABRAHAM |
| Designation |
POST GRADUATE |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
SRM MEDICAL COLLEGE HOSPITAL, ROOM NO 1, B BLOCK, DEPARTMENT OF ANAESTHESIOLOGY, POTHERI, KATTANKULATHUR
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9645633168 |
| Fax |
|
| Email |
reshmathankam96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR C R SARAVANAN |
| Designation |
PROFESSOR |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SRM MEDICAL COLLEGE HOSPITAL, SRM NAGAR, POTHERI, KATTANKULATHUR
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR C R SARAVANAN |
| Designation |
PROFESSOR |
| Affiliation |
SRM MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SRM MEDICAL COLLEGE HOSPITAL, SRM NAGAR, POTHERI, KATTANKULATHUR
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KATTANKULATHUR, POTHERI, TAMIL NADU, INDIA |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE HOSPITAL |
| Address |
Room no 1, B block, department of Anaesthesiology, potheri, kattankulathur 603203 Kancheepuram Tamilnadu |
| 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 RESHMA THANKAM ABRAHAM |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
ROOM NO 1, B BLOCK, DEPARTMENT OF ANAESTHESIOLOGY, POTHERI, KATTANKULATHUR 603203
Kancheepuram
TAMIL NADU |
9645633168
reshmathankam96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O745||Spinal and epidural anesthesia-induced headache during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
We will give nebulisation with dexmedetomidine 1 micrograms/kg diluted in 4ml 0.9% saline twice daily starting from the PDPH diadnosis and for 3 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed with PDPH post elective surgeries under spinal anesthesia
Age between 20- 40 years old
ASA I and ASA II.
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Pregnancy
Uncontrolled DM, HTN
History of chronic headache, migraine, convulsions, and cerebrovascular accident.
|
|
|
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 |
| Comparing the headache severity score |
Comparing the headache severity score at 24, 48 and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for epidural blood patch
Patient satisfaction score
Comparison of hemodynamic parameters
Analgesics consumption |
comparing at 24, 48, 72 hours after the onset of PDPH during post operative period |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/02/2025 |
| 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="0"
Months="6"
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
|
•Informed
written consent will be taken from all patients. Basic details will be
recorded. Baseline hemodynamic parameters will be noted.
•PDPH
was diagnosed by the four criteria of the International Classification of
Headache Disorders (ICH-II) guidelines which include a postural headache
develops within 5 days after lumbar puncture, worsens within 15 min of sitting
or standing and improves within 15 min after lying down, associated with at
least one of the following: neck stiffness, nausea, photophobia, and tinnitus,
and resolves either spontaneously within 1 week or within 48 h after effective
treatment of the CSF leak.
•Patients
who underwent spinal anaesthesia and developed PDPH, will be divided into 2
groups.
•GROUP
1: DEXMEDETOMIDINE GROUP -
received nebulisation with dexmedetomidine 1micro grams/kg diluted in 4ml 0.9%
saline twice daily starting from the PDPH diagnosis and for 3 days.
•GROUP
2: CONTROL GROUP -
received nebulisation with 4ml 0-9% saline twice daily starting from PDPH
diagnosis and for 3 days.
•Both
groups received conservative management, which consist of bed rest in supine
position, good hydration of 30ml/kg/day, paracetamol 1gm IV Q6H, oral caffeine
200mg Q6H, Diclofenac 75mg in 100ml NS infusion SOS.
|