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Clinical Trials/CTRI/2024/03/064208
CTRI/2024/03/064208
Not yet recruiting
Phase 4

Comparison of midazolam with propofol given at the end of surgery for prevention of emergence delirium in children undergoing infraumbilical abdominal surgery

ABVIMS DR RML HOSPITAL1 site in 1 country60 target enrollmentStarted: March 26, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
ABVIMS DR RML HOSPITAL
Enrollment
60
Locations
1
Primary Endpoint
Incidence of emergence delirium using Paediatric Anaesthesia Emergence Delirium(PAED) scale

Overview

Brief Summary

Emergence delirium is an acute state of confusion during recovery from anaesthesia. Incidence of emergence delirium in children ranges from 10 to 80% . Emergence delirium may have clinically significant consequences such as to patients or medical staffs, fallinf out of bed, bleeding at the surgical site, accidental removal of drain or intravenous catheters, unintented extubation , respiratory depression and increasing medical care cost. There is literature suggesting that some medication may prevent emergence delirium in children.Thus we plan to study the prevention of emergence delirium in children undergoing infraumbilical abdominal surgery by administering midazolam or propofol at the end of surgery.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
2.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA class 1&2.

Exclusion Criteria

  • Children with developmental delay, psychological and neurological disorders, abnormal airway, respiratory disease and cardiovascular diseases.

Outcomes

Primary Outcomes

Incidence of emergence delirium using Paediatric Anaesthesia Emergence Delirium(PAED) scale

Time Frame: At baseline

Secondary Outcomes

  • Recovery time, Duration of sevoflurane administration, FLACCS Score in both groups, any adverse effects like nausea/vomiting,laryngospasm,desaturation,bronchospasm(FLACCS score measured at baseline)

Investigators

Sponsor
ABVIMS DR RML HOSPITAL
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr. Safiqur Rahman

ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL,NEW DELHI

Study Sites (1)

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