Melatonin for Pediatric Emergence Agitation

Sponsor
Menoufia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05223010
Collaborator
(none)
117
1
3
3.1
38.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg
  • Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg
  • Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg
  • Drug: Sevoflurane
Phase 4

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
117 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics
Anticipated Study Start Date :
Jan 30, 2022
Anticipated Primary Completion Date :
Mar 2, 2022
Anticipated Study Completion Date :
May 3, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

39 participant will receive melatonin 0.05 mg/kg

Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg
will be administered 1 hour before arrival to operating room

Drug: Sevoflurane
for anaesthesia induction 3-8 MAC

Active Comparator: 2

39 participant will receive melatonin 0.2 mg/kg

Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg
will be administered 1 hour before arrival to operating room

Drug: Sevoflurane
for anaesthesia induction 3-8 MAC

Active Comparator: 3

39 participant will receive melatonin 0.4 mg/kg

Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg
will be administered 1 hour before arrival to operating room

Drug: Sevoflurane
for anaesthesia induction 3-8 MAC

Outcome Measures

Primary Outcome Measures

  1. emergence behaviour [5 min, 15 min and 30 min after arrival to recovery]

    change from baseline on a 5 point scale

Secondary Outcome Measures

  1. yale preoperative anxiety scale [before administration of oral premedication and before anaesthesia induction]

    3 domain scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 8 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, University Hospitals Shibīn Al Kawm Menoufia Egypt 32511

Sponsors and Collaborators

  • Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mostafa saieed fahim mansour, lecturer, Menoufia University
ClinicalTrials.gov Identifier:
NCT05223010
Other Study ID Numbers:
  • 1/2022ANET3-A
First Posted:
Feb 3, 2022
Last Update Posted:
Feb 3, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by mostafa saieed fahim mansour, lecturer, Menoufia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022