| CTRI Number |
CTRI/2019/11/022184 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of drugs fentanyl and dexmedetomidine for the treatment of headache after spinal anaesthesia |
|
Scientific Title of Study
|
Efficacy of Fentanyl and Dexmedetomidine nebulization for obstetric PDPH: A Randomised controlled pilot study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarjeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor ,B -Block
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarjeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor ,B -Block
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarjeet Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor ,B -Block
AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
9570890646 |
| Fax |
|
| Email |
amarjeetdmch@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Obstetric and gynaecology, B-Block, AIIMS, Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Patna |
Department of Obstetric and gynaecology, B-Block, AIIMS, Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amarjeet Kumar |
AIIMS, Patna |
Department of Obstetric and gynaecology,Gynae ward, B-Block
Patna
BIHAR |
9570890646
amarjeetdmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulization with dexmedetomidine 1µg/kg after PDPH |
Patient will be nebulized with dexmedetomidine dose 1µg/kg diluted with normal saline to total volume 4ml by using ultrasonic nebulizer 12 hrly for 3days. |
| Comparator Agent |
Nebulized with 4ml normal saline after PDPH |
Patient will be nebulized with volume 4ml normal saline using ultrasonic nebulizer 12 hrly for 3 days. |
| Intervention |
Nebulized with fentanyl 1µg/kg after PDPH |
Patient will be nebulized with fentanyl dose 1µg/kg diluted diluted with normal saline to total volume 4ml by using ultrasonic nebulizer 12 hrly for 3 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
. ASA I/II
.Complain of post spinal headache within 5 days following cesarean section |
|
| ExclusionCriteria |
| Details |
1. Unconscious and uncooperative patients
2. Allergic to dexmedetomidine/fentanyl
3 Asthmatics.
4. Epileptics
5. patient having history of migraine,other types headache
6.On chronic treatment of headache
7.Haemodynamic instability,bradyarrthymias
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Headache severity will be monitored using Numerical rating scale(NRS) |
Base line, during procedure, after procedure, hourly for the first 24 hours, followed by 2nd hourly next 24 hours and thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesic consumption |
Within 3days after development of PDPH |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/12/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Post dural puncture headache (PDPH) after spinal anaesthesia is excruciating in nature and some times associated with neck stiffness, tinnitus, photophobia and vomitining. Several drugs are used to control post dural puncture headache like paracetamol, caffeine, sumatriptan, dexmedetomidine, and others non-steroidal antiinflmatory drug.This study is designed to compare the analgesic effect of two different drug dexmedetomidine and fentanyl through inhalational route |