Comparison of effects of oral melatonin and alprazolam as preoperative medicine and their effects on post operative recovery in patients undergoing ear surgery

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/08/044912
• Lead Sponsor: Sharda Hospital

Brief Summary

Premedication has some important goals like relief of anxiety, sedation and analgesia. Preoperative anxiety is commonly experienced by the patients who are admitted to hospital for any surgery which can be described as an unpleasant state of tension or uneasiness that results from a patient’s doubts or fears about the surgery and anaesthesia. It increases patient’s catecholamine secretions which may lead to hypertension, tachycardia, and arrhythmias. Anxiety in surgical patients increases the need of anaesthetic drugs.

Benzodiazepines (midazolam and alprazolam) are most commonly used as a premedication to alleviate perioperative anxiety and to produce amnesia and sedation; however, they may impair cognitive and psychomotor performance. Alprazolam (triazolobenzodiazepine) is a short-acting drug which has anxiolytic, sedative, hypnotic, anticonvulsant, and amnesic properties but may cause psychomotor impairment.

Melatonin (N-acetyl-5-methoxytryptamine) is an endogenous neurohormone secreted by the pineal gland. It has unique property of producing anxiolysis with no impairment of cognitive and psychomotor function that is highly desirable in routine perioperative care when given orally as a premedication. It has inhibitory action on central nervous system. It also has sedative, hypnotic, analgesic, anti-inflammatory, antioxidative, and chronobiotic effects. The melatonin has been reported to be used as a premedication in a dose range of 3–15 mg given orally or sublingually 50–90 min preoperatively. The peak effect of oral melatonin ranges from 60 to 150 min. Hence, it is hypothesized that melatonin (6 mg) when given orally as a premedication 120 min before the induction of anaesthesia would provide adequate anxiolysis and arousable sedation with no effect on cognitive and psychomotor function along with stable hemodynamics and minimal side effects. In this study, we plan to compare the effects of oral melatonin and alprazolam as a premedication on various parameters including anxiety, sedation, cognition, psychomotor function and analgesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patient undergoing tympanoplasty surgeries under general anaesthesia 2.
• ASA class I and II.

Exclusion Criteria

• Patient refusal to participate in the study 2.
• Patients receiving steroids, analgesics, antiemetic, sedatives and antipsychotics.
• Patients having history of endocrine, cardiovascular, renal or CNS disease.
• Patients allergic to study drugs.
• BMI > 30 kg m-2 6.
• Patient having chronic pain and any mental illness 7.
• Pregnant patients 8.
• Patients with inability to read and write basic alphabets and numbers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effects of melatonin and alprazolam on preoperative anxiety.	2 hours post surgery

Secondary Outcome Measures

Name	Time	Method
1. To compare the effects of melatonin and alprazolam on:	(a) Pre-operative sedation

Trial Locations

Locations (1)

Sharda Hospital, School of Medical science and Research; 🇮🇳 Nagar, UTTAR PRADESH, India

Sharda Hospital, School of Medical science and Research

🇮🇳Nagar, UTTAR PRADESH, India

Nupoor

Principal investigator

9717912144

nupoor.1@sharda.ac.in