Comparison of magnesium sulphate versus dexmeditomidine as an adjuvant to ropivacaine for caudal block in paediatric surgeries : a prospective randomized double blind study.

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/08/035876
• Lead Sponsor: Dr YENDETI AMRUTHA

Brief Summary

This study is a comparision of analgesic efficacy of magnesium sulphate versus dexmeditomidine as an adjuvant to 0.25% ropivacaine for caudal block in paediatric infra umblical surgeries: a prospective randomized double blind study that will be conducted in sri sathya sai institute of higher medical sciences . The primary outcome  measures duration of analgesia ,secondary outcome will be to study the haemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure,mean arterial pressure,spo2,respiratory rate),onset of analgesia,residual motor block,sedation score,adverse effects such as nausea,vomiting,bradycardia,hypotension,respiratory depression.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-13
• Study Start: 2021-08-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Children with informed written consent from their parents.
• Children posted for infra umbilical surgeries.
• American Society Anesthesiologists (ASA) physical status Grade I and II.
• Age between 2 to 10 years of either sex.

Exclusion Criteria

• Anatomical malformation of spine ii.
• History of neurological and neuromuscular disorders.
• Coagulation abnormalities iv.
• Patients with infection at local site.
• Patients with known allergy to local anesthetics.
• Patient with bloody tap and dural puncture during caudal block.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	Post-operative analgesia will be monitored through The Face, Legs, Activity, Cry, Consolability (FLACC) pain score immediately with recovery, and every 30 min until the 2nd hour, then at the 4th, 6th, 12th,18th, and 24th hours

Secondary Outcome Measures

Name	Time	Method
1. Hemodynamic parameters(Heart rate (HR), Systolic BP(SBP), Diastolic BP(DBP) , Mean Arterial Pressure (MAP), SpO2, Respiratory rate(RR) )	2. Onset of analgesia

Trial Locations

Locations (1)

SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES; 🇮🇳 Anantapur, ANDHRA PRADESH, India

SRI SATHYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES

🇮🇳Anantapur, ANDHRA PRADESH, India

DR YENDETI AMRUTHA

Principal investigator

9487739634

yendeti_amrutha@yahoo.com