Melatonin for Pediatric Emergence Agitation
Study Details
Study Description
Brief Summary
efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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
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
- emergence behaviour [5 min, 15 min and 30 min after arrival to recovery]
change from baseline on a 5 point scale
Secondary Outcome Measures
- yale preoperative anxiety scale [before administration of oral premedication and before anaesthesia induction]
3 domain scale
Eligibility Criteria
Criteria
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.- 1/2022ANET3-A