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The effect of melatonin pre-treatment on the consumption of inhaled anaesthetic in children undergoing planned surgery.

To evaluate the effect of melatonin premedication on Bispectral Index guided sevoflurane consumption in pediatric surgery: A randomized controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/062064
Enrollment
140
Registered
2024-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Melatonin: Group M - Melatonin 0.2 mg per Kg (maximum dose 10mg) as syrup reconstituted with honey to a volume of 5 ml 1 hour before surgery with sips of water Control Intervention1: G

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists grade I or II paediatric patients (aged from 2 to 8 years) undergoing elective surgical procedure under general anaesthesia (Duration of procedure ranging from 30 minutes to 2 hours).

Exclusion criteria

Exclusion criteria: Unwillingness to participation. Paediatric patients undergoing elective surgical procedure under general anaesthesia from department of Cardiothoracic and Neurosurgery. Patients with known comorbidities (renal or hepatic derangement, Asthma, TB, etc). Allergy to Study drugs or Honey. History of epileptic seizures, psychoactive medications, neurological disorders, or trauma.

Design outcomes

Primary

MeasureTime frame
To assess the effect of melatonin premedication on total sevoflurane consumption. Inhaled sevoflurane requirement (volume%) will be measured to maintain BIS readings between 40 to 50 using Dion method.Timepoint: 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 60 minutes, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes and 120 minutes after induction of anaesthesia.—

Secondary

MeasureTime frame
To assess the Duration of first analgesic requirement in post operative period. Timepoint: Post operative period. ;To assess the effect on anxiety scores (Modified yale preoperative Anxiety Scale).Timepoint: 0 minutes, 30 minutes, 60 minutes after premedication and at induction of anaesthesia.;To assess the effect on Pain scores (FLACC Scale) during post operative period.Timepoint: 0 minute, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 18 hours, 24 hours in post operative period.;To assess the effect on sedation scores (Ramsay Sedation Scale).Timepoint: 0 minutes, 30 minutes, 60 minutes after premedication and at induction of anaesthesia.;To assess the effect on Total analgesic requirement during post operative period. (Injection Fentanyl 0.5 mcg per kg IV).Timepoint: Till 24 hours in post operative period.—

Countries

India

Contacts

Public ContactYashwant Singh Payal

AIIMS Rishikesh

dryspayal05@gmail.com9411789762

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026