MedPath

A clinical trial on comparison of Ketamine-Propofol combination with or without Fentanyl for sedation in children undergoing surgeries below the umbilicus under spinal anaesthesia

Phase 1
Conditions
Health Condition 1: null- AGE 3-8 YEARS ASA GRADE I AND II
Registration Number
CTRI/2018/03/012590
Lead Sponsor
Vardhman Mahavir Medical College
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Children aged 3 â??8 years belonging to American Society of Anaesthesiologists (ASA) grade I & II undergoing infraumbilical surgery with tentative duration of surgery <= 90 minutes.

Exclusion Criteria

Any contraindications for neuraxial blockade- spinal deformities, local site infection, known case of coagulopathy, raised ICP etc.

Known allergy to local anaesthetic agents, propofol.

Patients with systemic disease, neurological impairment, airway abnormality, Intercurrent URTI

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess intraoperative pediatric sedation state scale and postoperative Modified aldrete score using ketamine and propofol combination with or without fentanyl for sedation in these children.Timepoint: intra operative period and post operative period
Secondary Outcome Measures
NameTimeMethod
To assess intraoperative and postoperative haemodynamic and respiratory parameters using ketamine and propofol combination with or without fentanyl for sedation in these children.Timepoint: INTRAOPERATIVE AND POST OPERATIVE PERIOD
© Copyright 2025. All Rights Reserved by MedPath