Skip to content

Giving melatonin 2 hours before surgery to see its effects on blood pressure and heart rate in older patients.

Effects of Oral Melatonin Premedication on Attenuation of Haemodynamic Response to Intubation and Anaesthetic Requirements in Geriatric Patients: A Randomized Clinical Trial - nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084520
Enrollment
70
Registered
2025-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: K80- Cholelithiasis

Interventions

Intervention1: Tablet Melatonin: Melatonin (N-acetyl-5-methoxytryptamine) is an endogenous sleep regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep on

Sponsors

Hamdard Institute of Medical Sciences and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: This prospective, randomized, double-blind study will be conducted on 70 patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1.Patient not consenting 2.Known or anticipated difficult airway 3.Morbid Obesity 4.History of mental illness 5.Known Allergy to the study drug 6.History of GERD 7.Patient on Antipsychotic, Sedatives, Anxiolytics, Antiepileptics 8.Patient having History of Sleep Disorders

Design outcomes

Primary

MeasureTime frame
compare the effect of oral melatonin premedication versus placebo on changes in Systolic Blood Pressure following intubation.Timepoint: Baseline in Operation theatre, After induction, before intubation, after intubation, 1 minute post intubation, 3 minute post intubation, 5 minute post intubation, 10 minute post intubation, creation of pneumoperitneum

Secondary

MeasureTime frame
1)To compare the effects of oral melatonin premedication on changes in Diastolic Blood Pressure, Mean Arterial Pressure and heart rate following intubation between the groups. 2)To compare the propofol dose required for induction of general anaesthesia 3)To compare the intraoperative requirement of isoflurane and fentanyl Timepoint: Baseline in Operation theatre, After induction, before intubation, after intubation, 1 minute post intubation, 3 minute post intubation, 5 minute post intubation, 10 minute post intubation, creation of pneumoperitneum

Countries

India

Contacts

Public ContactRia Tyagi
pratibha.panjiar@gmail.com9311657822

Outcome results

None listed

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