Effects of Oral Melatonin Premedication on Attenuation of Haemodynamic Response to Intubation and Anaesthetic Requirements in Geriatric Patients: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- compare the effect of oral melatonin premedication versus placebo on changes in Systolic Blood Pressure following intubation.
Study Overview
Brief Summary
We aim to evaluate the effects of oral melatonin (6 mg) on hemodynamic responses to intubation and anesthetic requirements in geriatric patients undergoing laparoscopic cholecystectomy.
Background & Rationale:
Intubation triggers sympathetic activation, leading to increased heart rate and blood pressure, which can be harmful to elderly patients with cardiovascular conditions.
Commonly used drugs (opioids, beta-blockers, benzodiazepines) can cause adverse effects like hypotension, respiratory depression, and bradycardia.
Melatonin, a naturally occurring hormone, has sedative, anxiolytic, and hemodynamic stabilizing properties with minimal side effects.
The hemodynamic responses are noted at various times.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 65.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •This prospective, randomized, double-blind study will be conducted on 70 patients undergoing laparoscopic cholecystectomy under general anaesthesia.
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.
Outcomes
Primary Outcomes
compare the effect of oral melatonin premedication versus placebo on changes in Systolic Blood Pressure following intubation.
Time Frame: 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 Outcomes
- 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.
Investigators
Ria Tyagi
Hamdard Institute of Medical Sciences and Research