| CTRI Number |
CTRI/2025/09/094940 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| 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
|
Comparison between intravenous Dexamethasone and intravenous Ondansetron for prevention of low blood pressure after spinal anesthesia in caesarean delivery among pregnant women |
|
Scientific Title of Study
|
Comparison between intravenous Dexamethasone and intravenous Ondansetron for prevention of post spinal hypotension in patients undergoing elective lower segment caesarean section : A randomized 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 |
Shailendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room Number 4, Porta Cabin, 5th floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor Academic block, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8745027472 |
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shailendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room Number 4, Porta Cabin, 5th floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor Academic block, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
8745027472 |
| Fax |
|
| Email |
drshail.kumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indrani Das |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number 5011, Anaesthesiology office, Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor academic block, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9564618400 |
| Fax |
|
| Email |
indranimistu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology , Pain Medicine And Critical Care, AIIMS New Delhi,Ansari Nagar 110029 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrShailendra Kumar |
AIIMS New Delhi |
Room No 4, Porta Cabin, 5th Floor, Academic Building, Department of Anaesthesiology, Pain Medicine and Critical Care,AIIMS New Delhi, 110029
South
DELHI |
8745027472
drshail.kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj 0.9% Normal saline 30 minutes prior to spinal anaesthesia |
On the morning of surgery 10 ml of 0.9% normal saline will be given intravenously over 5 minutes in the study group C 30 minutes before spinal anaesthesia. |
| Intervention |
Intravenous Dexamethasone and intravenous Ondansetron 30 minutes prior to spinal anaesthesia |
On the morning of surgery Inj Dexamethasone 8 mg diluted in 0.9% normal saline (total volume 10 ml) and inj Ondansetron 8 mg diluted in 0.9% normal saline (total volume 10 ml) will be given intravenously over 5 minutes in the study group A and B respectively 30 minutes before spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women undergoing elective LSCS under Spinal anaesthesia
3. Singleton pregnancy
4. American society of anaesthesiologists physical status( ASA) 2
5. Gestational age more than 37 weeks
|
|
| ExclusionCriteria |
| Details |
1. Gestational diabetes mellitus
2. Chronic diabetes mellitus
3. Hypertensive disorders of pregnancy
4. Cardiovascular insufficiency
5. BMI more than 40 kg/m2
6. Allergy to Dexamethasone or Ondansetron
7. Long QTsyndrome
8. Patients on long term steroid treatment
9. Any contraindication to spinal anaesthesia
10. Patient refusal
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of post spinal hypotension between the study groups |
• Systolic blood pressure will be recorded every 1 minutes till delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the number of boluses of Phenylephrine |
|
| 2. To compare incidence of post delivery hypotension |
Systolic blood pressure will be measured every 5 minutes after delivery till the end of the surgery |
| 3. To compare the incidence of maternal bradycardia, nausea/vomiting, shivering |
|
| 4. To compare the neonatal outcome (APGAR Score, umbilical artery Ph, blood sugar |
|
| 5. Quality of recovery (QoR 15) |
on the morning of surgery and 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="285"
Sample Size from India="285"
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)
|
01/10/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
Sub arachnoid block is the preferred anaesthesia for elective LSCS as it has better maternal and fetal outcome as compared to general anaesthesia. Most common side effect of spinal anaesthesia is post spinal hypotension with an incidence ranging from 50 to 80 % in patients undergoing LSCS. Post spinal hypotension can lead to serious maternal as well as fetal compromise due to reduced umbillical blood flow prior to delivery. Hence it is necessary to address this condition. Various pharmacological and non pharmacological agents have been tried to prevent and treat post spinal hypotension with varying degrees of effectiveness. Dexamethasone is relatively newer agent and it has shown promising outcome in preventing post spinal hypotension during LSCS. But its exact efficacy is yet to be proven . Ondansetron is an established drug for prevention of post spinal hypotension. Therefore our study aims to compare the efficacy of intravenous Dexamethasone and Intravenous Ondansetron for prevention of post spinal hypotension in elective LSCS as Dexamethasone is comparatively safer alternative for pregnant women with respect to Ondansetron. |