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Melatonin for Pediatric Emergence Agitation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05223010
Enrollment
117
Registered
2022-02-03
Start date
2022-01-30
Completion date
2022-12-03
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

Keywords

melatonin, emergence agitation

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

Interventions

DRUGMelatonin 5 MG/15 ML Oral Solution 0.05 mg/kg

will be administered 1 hour before arrival to operating room

DRUGMelatonin 5 MG/15 ML Oral Solution 0.2mg/kg

will be administered 1 hour before arrival to operating room

DRUGMelatonin 5 MG/15 ML Oral Solution 0.4mg/kg

will be administered 1 hour before arrival to operating room

DRUGSevoflurane

for anaesthesia induction 3-8 MAC

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
emergence behaviour5 min, 15 min and 30 min after arrival to recoverychange from baseline on a 5 point scale

Secondary

MeasureTime frameDescription
yale preoperative anxiety scalebefore administration of oral premedication and before anaesthesia induction3 domain scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026