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Completed

NCT Number: NCT05223010

Melatonin for Pediatric Emergence Agitation

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

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

will be administered 1 hour before arrival to operating room

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

Drug

will be administered 1 hour before arrival to operating room

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

Drug

will be administered 1 hour before arrival to operating room

Sevoflurane

Drug

for anaesthesia induction 3-8 MAC

Primary outcomes

  1. emergence behaviour

    Time frame: 5 min, 15 min and 30 min after arrival to recovery

    change from baseline on a 5 point scale

Secondary outcomes

  1. yale preoperative anxiety scale

    Time frame: before administration of oral premedication and before anaesthesia induction

    3 domain scale

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2022
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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