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Clinical Trials/NCT05223010
NCT05223010
Completed
Phase 4

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

Menoufia University1 site in 1 country117 target enrollmentJanuary 30, 2022

Overview

Phase
Phase 4
Intervention
Sevoflurane
Conditions
Emergence Agitation
Sponsor
Menoufia University
Enrollment
117
Locations
1
Primary Endpoint
emergence behaviour
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 30, 2022
End Date
December 3, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

mostafa saieed fahim mansour

lecturer

Menoufia University

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

2

39 participant will receive melatonin 0.2 mg/kg

Intervention: Sevoflurane

1

39 participant will receive melatonin 0.05 mg/kg

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

1

39 participant will receive melatonin 0.05 mg/kg

Intervention: Sevoflurane

2

39 participant will receive melatonin 0.2 mg/kg

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

3

39 participant will receive melatonin 0.4 mg/kg

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

3

39 participant will receive melatonin 0.4 mg/kg

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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

  • yale preoperative anxiety scale(before administration of oral premedication and before anaesthesia induction)

Study Sites (1)

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