Melatonin for Pediatric Emergence Agitation

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223010
• Other study ID #: 1/2022ANET3-A
• Status: Completed
• Phase: Phase 4
• Start date: January 30, 2022
• Est. completion date: December 3, 2022

Study information

• Verified date: October 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 3, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	emergence behaviour	change from baseline on a 5 point scale	5 min, 15 min and 30 min after arrival to recovery
Secondary	yale preoperative anxiety scale	3 domain scale	before administration of oral premedication and before anaesthesia induction