A comparative study of ketamine and dexmedetomidine versus ketamine and fentanyl for intravenous sedation in children undergoing infraumbilical surgeries under spinal anaesthesia

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/10/046610
• Lead Sponsor: Vijayanagar institute of medical sciences

Brief Summary

The aim of this randomized controlled trial study is to compare the effect of Ketamine -dexmedetomidine and ketamine-fentanyl combination as an IV sedation on analgesia, quality of intraoperative sedation, homodynamic changes and recovery characteristics in children undergoing infraumbilical surgeries under spinal anaesthesia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-18
• Study Start: 2022-10-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All ASA physical status 1 and 2,belonging to 2-8yr age group of either sex posted for elective infraumbilical sugeries.

Exclusion Criteria

(a)Parent’s refusal for the study (b)Children with any contraindication for spinal anaesthesia (c)Significant cardiovascular, respiratory, CNS, renal system and endocrinal disorders (d)Allergy to the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare quality of sedation by using Modified Observer’s Assessment Alertness/Sedation (MOAA/S) scale	From premedication to the recovery of patient from sedation

Secondary Outcome Measures

Name	Time	Method
To compare	1)Intraoperative hemodynamic changes

Trial Locations

Locations (1)

Vijayanagar institute of medical sciences; 🇮🇳 Bellary, KARNATAKA, India

Vijayanagar institute of medical sciences

🇮🇳Bellary, KARNATAKA, India

Syeda Maryam Quadri

Principal investigator

8971100393

maryamquadri23@gmail.com