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CTRI Number  CTRI/2022/03/040772 [Registered on: 03/03/2022] Trial Registered Prospectively
Last Modified On: 23/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparison of intravenous vs intrathecal dexamethasone on prevention of post op nausea and vomiting in caesarean section 
Scientific Title of Study   Comparison of the effect of intravenous and inrathecal dexamethasone on prevention of post op nausea and vomiting in patients posted for caesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat Paliwal 
Designation  Associate Professor, Dept of Anaesthesiology and Critical Care 
Affiliation  AIIMS,Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Department of Anaesthesiology and Critical Care MIA phase II,Basni
All India Institute of Medical Sciences, Jodhpur, Department of Anaesthesiology and Critical Care MIA phase II, Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  09588089378  
Fax    
Email  docbpali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharat Paliwal 
Designation  Associate Professor, Dept of Anaesthesiology and Critical Care 
Affiliation  AIIMS,Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Department of Anaesthesiology and Critical Care MIA phase II, Basni
All India Institute of Medical Sciences, Jodhpur Department of Anaesthesiology and Critical Care MIA phase II, Basni
Jodhpur
RAJASTHAN
342005
India 
Phone  9588089378  
Fax    
Email  docbpali@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharat Paliwal 
Designation  Associate Professor, Dept of Anaesthesiology and Critical Care 
Affiliation  AIIMS,Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Department of Anaesthesiology and Critical Care MIA phase II, Basni
All India Institute of Medical Sciences, Jodhpur Department of Anaesthesiology and Critical Care MIA phase II, Basni
Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  docbpali@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur, DEPT OF ANAESTHESIOLOGY AND CRITICAL CARE, MIA, PHASE II, BASNI, JODHPUR, RAJASTHAN 342005 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  AIIMS JODHPUR 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MUKUND SAJJAN  OT Complex, 2nd Floor  AIIMS Jodhpur, Department of Anaesthesiology and Critical Care MIA phase II, Basni
Jodhpur
RAJASTHAN 		 09786171500

sajju.sj@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Jodhpur INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Group A  Intrathecal dexamethasone 4 mg(1ml) and intravenous normal saline (1ml)  
Intervention  Group B  The study will be conducted on patients undergoing CS under spinal anesthesia with local anaesthetic (LA) solution containing 1.5 ml bupivacaine heavy(0.5%). Before surgery, patients will be acquainted with visual analogue scale. The study participants will be allocated to one of the of 3 groups based on random number table: GROUP-B: Intravenous dexamethasone 4mg and intrathecal saline 1ml The group allocation numbers will be concealed in sealed opaque envelopes that will be opened only after shifting the patient to preoperative holding area by a person not involved in the study. The monitors attached will include non-invasive blood pressure (NIBP), electrocardiography (ECG), and peripheral oxygen saturation (SPO2). An 18 G I.V cannula will be secured in one hand and fluid will be started. DOSE: 1.5 ML BUPIVACAINE 1ML DEXAMETHASONE 1 ML NORMAL SALINE ROUTE: INTRATHECAL/ INTRAVENOUS FREQUENCY OF ADMINISTRATION: ONCE BEFORE THE START OF LSCS  
Comparator Agent  Group C  Control group receiving 1ml of intravenous and intrathecal saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant patients undergoing emergency/elective
Cesarian Section under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1. Refusal of informed consent
2. Hemodynamic instability
3. Patients having an allergic reaction to steroids
4. Fever or infection
5. Patient with an underlying medical condition with long term use of steroids
6. Patients having pregnancy-associated complications(hyperemesis gravidarum)
7. History of gastrointestinal disorders, motion disorders
8. Use of an antiemetic drug received before surgery
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to find the efficacy of intravenous and intrathecal dexamethasone on preventing the PONV in pregnant patients undergoing caesarean section (CS) under spinal anaesthesia measured in terms of number of episodes of nausea and/or vomiting in 24 hours postoperatively.  Episodes within 24 hrs  
 
Secondary Outcome  
Outcome  TimePoints 
Total antiemetic consumption

Onset of sensory block

Duration of anesthesia

Defined as time from onset of sensory block, to first rescue analgesic patient demand VAS3

Total analgesic consumption in 24 hours

Quality of analgesia

To assess the adverse effects  		 24 HRS 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/03/2022 
Date of Study Completion (India) 30/12/2022 
Date of First Enrollment (Global)  10/03/2022 
Date of Study Completion (Global) 30/12/2022 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 The study will be published after completion  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  All of the individual participant data collected during the trial, after de-identification

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response (Others) -  Study Protocol Statistical Analysis Plan Informed Consent Form
  3. Who will be able to view these files?
    Response (Others) -  Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response (Others) -  To achieve aims in the approved proposal

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to email ID docbpali@gmail.com. To gain access, data requestors will need to sign a data access agreement.

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 01-12-2023?
    Response (Others) -  After assessment of request through email (docbpali@gmail.com)

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NO
Brief Summary
Modification(s)  		 .

AIM: To assess the effect of intravenous and intrathecal dexamethasone on the prevention of PONV in patients posted for CS

OBJECTIVES:

Primary:

To find the efficacy of intravenous and intrathecal dexamethasone on preventing the PONV in pregnant patients undergoing cesarean section (CS) under spinal anaesthesia measured in terms of number of episodes of nausea and/or vomiting in 24 hours postoperatively.

 Secondary:

1. Total antiemetic consumption in 24hrs

2.   Onset of sensory block(Block completion to grade 1 sensory block)

3.   Duration of analgesia defined as the time from onset of sensory block to first rescue analgesic(patient demand/VAS>3)

4.  Total analgesic consumption in 24 hrs

5. Quality of analgesia (VAS)

6. To assess the adverse effects/complication, if any

7. Patient satisfaction (Likert Scale)

 The study involves 3 groups. The 1st group will be receiving intrathecal dexamethasone (1ml) and bupivacaine of 1.5 ml with intravenous normal saline of 1 ml

The 2nd group will be receiving intrathecal bupivacaine (1.5 ml) and normal saline (1ml) with intravenous dexamethasone (1ml)

The 3 rd control group will be receiving both normal saline in intravenous and intra thecal group along with 1.5 ml of intrathecal bupivacaine

 
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