NCT05223010

Melatonin for Pediatric Emergence Agitation

Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

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

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
DRUG	Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg	will be administered 1 hour before arrival to operating room
DRUG	Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg	will be administered 1 hour before arrival to operating room
DRUG	Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg	will be administered 1 hour before arrival to operating room
DRUG	Sevoflurane	for anaesthesia induction 3-8 MAC

Timeline

• Start date: 2022-01-30
• Primary completion: 2022-06-02
• Completion: 2022-12-03
• First posted: 2022-02-03
• Last updated: 2023-10-12

Locations

1 site across 1 country: Egypt