Melatonin for Pediatric Emergence Agitation

Phase 4

Completed

• Conditions: Emergence Agitation
• Interventions: Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg; Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg; Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg; Drug: Sevoflurane

• Registration Number: NCT05223010
• Lead Sponsor: Menoufia University

Brief Summary

efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries

Detailed Description

Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.

Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-22
• Study Start: 2022-01-30
• Study First Posted: 2022-02-03
• Primary Completion: 2022-06-02
• Study Completion: 2022-12-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• ASA I
• scheduled for unilateral inguinal herniorrhaphy
• parents conscent

Exclusion Criteria

• allergy to this study drug
• Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg	39 participant will receive melatonin 0.05 mg/kg
1	Sevoflurane	39 participant will receive melatonin 0.05 mg/kg
2	Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg	39 participant will receive melatonin 0.2 mg/kg
2	Sevoflurane	39 participant will receive melatonin 0.2 mg/kg
3	Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg	39 participant will receive melatonin 0.4 mg/kg
3	Sevoflurane	39 participant will receive melatonin 0.4 mg/kg

Primary Outcome Measures

Name	Time	Method
emergence behaviour	5 min, 15 min and 30 min after arrival to recovery	change from baseline on a 5 point scale

Secondary Outcome Measures

Name	Time	Method
yale preoperative anxiety scale	before administration of oral premedication and before anaesthesia induction	3 domain scale

Trial Locations

Locations (1)

Faculty of Medicine, University Hospitals; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt