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Effects of oral melatonin on heart rate and blood pressure responses and sedation in patients undergoing surgeries under general anaesthesia

Effects of oral melatonin premedication on haemodynamic responses to intubation, intraoperative anaesthetic requirements and level of sedation in patients undergoing surgeries under general anaesthesia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033532
Enrollment
50
Registered
2021-05-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E049- Nontoxic goiter, unspecified

Interventions

Intervention1: Melatonin: One group of patients will be given Tab melatonin 6mg orally, 120 minutes before surgery. The drug will be given only once Control Intervention1: Placebo: One group of patien

Sponsors

Amrita Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing total thyroidectomy ASA PS â?? I and II

Exclusion criteria

Exclusion criteria: 1. Anticipated difficult airway, 2. Those requiring >1 attempt or >15sec for laryngoscopy, use of bougie 3. BMI >30 kg/m2, 4. patients on antipsychotic, sedatives, anxiolytics and antiepileptic drugs, rate controlling medications 5. Known allergy to melatonin

Design outcomes

Primary

MeasureTime frame
To compare heart rate response at 1 min after intubation in patients following oral premedication with melatonin versus placebo 2 hours before surgery.Timepoint: At one minute after intubation

Secondary

MeasureTime frame
Changes in heart rate, blood pressure, intraoperative requirement of fentanyl and isoflurane, preoperative and postoperative sedation will be comparedTimepoint: before and after premedication, before and after induction,1, 3, 5 and 10 min following intubation and after surgery

Countries

India

Contacts

Public ContactDr Reema Abubaker

Amrita Institute of Medical Sciences

sunilrajan@aims.amrita.edu9447464652

Outcome results

None listed

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