Melatonin for Pediatric Emergence Agitation

Menoufia University

Status and phase: Completed; Phase 4

Conditions: Emergence Agitation

Treatments: Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg; Drug: Sevoflurane; Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg; Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT05223010

1/2022ANET3-A

Details and patient eligibility

About

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

Full 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

Enrollment: 117 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 3 patient groups

1

Active Comparator group

Description:

39 participant will receive melatonin 0.05 mg/kg

Treatment:

Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg

Drug: Sevoflurane

2

Active Comparator group

Description:

39 participant will receive melatonin 0.2 mg/kg

Treatment:

Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg

Drug: Sevoflurane

3

Active Comparator group

Description:

39 participant will receive melatonin 0.4 mg/kg

Treatment:

Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg

Drug: Sevoflurane