comparison of intravenous vs intrathecal dexamethasone on prevention of post op nausea and vomiting in caesarean section

Phase 1/2

Not yet recruiting

• Conditions: Encounter for full-term uncomplicated delivery,

• Registration Number: CTRI/2022/03/040772
• Lead Sponsor: AIIMS JODHPUR

Brief Summary

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**AIM:**To assess the effect of intravenous and intrathecal dexamethasone on the prevention of PONVinpatients 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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-03
• Study Start: 2022-10-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Pregnant patients undergoing emergency/elective Cesarian Section under spinal anaesthesia.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Total antiemetic consumption	Onset of sensory block

Trial Locations

Locations (1)

OT Complex, 2nd Floor; 🇮🇳 Jodhpur, RAJASTHAN, India

OT Complex, 2nd Floor

🇮🇳Jodhpur, RAJASTHAN, India

MUKUND SAJJAN

Principal investigator

09786171500

sajju.sj@gmail.com