Investigating the effect of propofol, ketamine and ketofol on agitation after herniorrhaphy

Phase 3

• Conditions: Agitation after surgery.; Restlessness and agitation; R45.1

• Registration Number: IRCT20201207049639N9
• Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Children undergoing herniorrhaphy under general anesthesia
Aged between 2-4 years
Patients with physical status classified as ASA II and ASA III according to the criteria of the American Anesthesia Association (ASA).

Exclusion Criteria

Mental retardation
Neurological diseases
Anomaly of the upper airway
History of asthma or other lung diseases
Pulmonary infections in the last 4 weeks

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agitation score. Timepoint: After extubation, the time to leave the operating room, recovery and 30 minutes after surgery. Method of measurement: Four-point scale for assessing of agitation.

Secondary Outcome Measures

Name	Time	Method
Pain severity. Timepoint: Recovery, 30 minutes after surgery. Method of measurement: Consolability cry activity leg face (FLACC ).;Heart rate. Timepoint: Every 15 minutes to one hour, and at hours 6, 12, and 24 after surgery. Method of measurement: Pulse oximetry.;Vomiting. Timepoint: Within 24 hours after surgery. Method of measurement: Clinical examination.