| CTRI Number |
CTRI/2024/03/064741 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Intravenous Ondansetron and Hydrocortisone combination in prevention of headache after spinal anaesthesia in pregnant women undergoing caesarean section |
|
Scientific Title of Study
|
Role of Ondansetron and Hydrocortisone combination in prevention of PDPH after spinal anaesthesia for caesarean section |
| 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 MANOJ DASS L |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Hospital, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9952786911 |
| Fax |
|
| Email |
manojdass222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Shenoy |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Hospital, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9448911261 |
| Fax |
|
| Email |
drlaxmishenoy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Shenoy |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Hospital, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9448911261 |
| Fax |
|
| Email |
drlaxmishenoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Manoj Dass L |
| Address |
Junior Resident,
Department of Anaesthesiology,
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.
|
| 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 Manoj Dass L |
Kasturba Medical College |
Department of Anaesthesiology, Women and Child Operation Theatre Complex.
Udupi
KARNATAKA |
9952786911
manojdass222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Participants in this group will receive single dose intravenous Normal Saline 10 ml after baby delivery |
| Intervention |
Ondansetron and Hydrocortisone |
Participants in this group will receive single dose intravenous Ondansetron 4 mg and intravenous Hydrocortisone 100 mg after the baby delivery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Parturient posted for elective caesarean sections with American Society of anaesthesiologists physical status 2, with Body mass index of less tha 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Parturient unwilling to participate in study, with history of chronic steroid use, history of migraine, preeclampsia, eclampsia, gestational diabetes mellitus |
|
|
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 |
| To compare the incidence of Post dural puncture headache at 24 hrs, 48hrs, 72 hrs and follow up upto a week in parturient who have received the prophylactic combination of ondansetron and Hydrocortisone versus the control group who have not received any of the above prophylactic medications |
To compare the incidence of Post dural puncture headache at 24 hrs, 48hrs, 72 hrs and follow up upto a week in parturient who have received the prophylactic combination of ondansetron and Hydrocortisone versus the control group who have not received any of the above prophylactic medications |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of Postoperative Nausea and vomiting between the two groups |
occurrence of nausea and vomiting till 3 days postop |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Spinal anaesthesia is one of the most commonly used anaesthetic technique for caesarean delivery, but it always carries a risk of PDPH which can occur despite maximum care to prevent it. No studies have been done regarding prophylactic use of combination of Ondansetron and hydrocortisone in prevention of PDPH, even though individually each drug has been studied for treatment/prevention of PDPH. |