To assess the effect of different doses of tablet melatonin (used as sedative, anxiolytic, antihypertensive drug) in reducing blood pressure and heart rate response while inserting a tube in trachea for providing general anaesthesia

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/03/032123
• Lead Sponsor: Reshma B M

Brief Summary

- Melatonin is a endogenous sleep regulating hormone secreted by pineal gland responsible for various physiological functions like circadian rythm, reproductive function, mood and immune function.(1) It has inhibitory action on central nervous system responsible for sedation and anxiolysis thus having role in attenuating haemodynamic response to laryngoscopy and intubation.(2)

- In our study, we compare two different doses 6mg and 9mg of oral melatonin,  given as a premedication 2 hours before surgery in attenuating the haemodynamic responses to laryngoscopy and intubation.



- We hypothesize, that melatonin 9mg is more effective in attenuating haemodynamic response to laryngoscopy and intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study Completion: 2021-11-26
• Last Update Posted: 2023-02-04

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients undergoing elective surgeries under general anaesthesia 2.
• Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) 1 and 2.

Exclusion Criteria

• Refusal to consent for study 2.
• Allergy to melatonin 3.
• Patients receiving treatment with study drug (melatonin) 4.
• Anticipated difficult intubation [Modified Mallampati class 3 and 4] 5.
• More than 2 intubation attempts or intubation time more than 15 seconds 6.
• Patients with uncontrolled hypertension and diabetes.
• Patients with severe cardiac, renal or hepatic disease.
• Pregnancy and lactation.
• Patients on hypnotics, sedatives, anxiolytics, anti-epileptics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the blood pressure (BP) and heart rate (HR) following laryngoscopy and	Baseline, every minute for | 5 minutes, 10th and 15th minute after intubation
To evaluate the effect of oral melatonin 6mg compared with 9mg in attenuating	Baseline, every minute for | 5 minutes, 10th and 15th minute after intubation
intubation.	Baseline, every minute for | 5 minutes, 10th and 15th minute after intubation

Secondary Outcome Measures

Name	Time	Method
1.To assess the level of sedation and anxiety scores before induction of	anaesthesia.

Trial Locations

Locations (1)

Dr B.R. Ambedkar medical hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dr B.R. Ambedkar medical hospital

🇮🇳Bangalore, KARNATAKA, India

Reshma B M

Principal investigator

8892019120

lucky3276@gmail.com