Evaluation of the effect of melatonin(sleep-wake regulating hormone) premedication on preoperative anxiety, propofol(general anaesthetic) induction dosage, perioperative haemodynamics(blood pressure,heart rate) and quality of recovery : An exploratory study

Phase 3

Not yet recruiting

• Registration Number: CTRI/2021/09/036209
• Lead Sponsor: Manasmita Dalai

Brief Summary

Melatonin is expected to decrease preoperative anxiety and improve quality of recovery 15 score compared to alprazolam

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-07-08
• Study Start: 2021-10-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Female Patient 3.
• 18 to 65 years of age undergoing elective laparoscopic gynaecological surgery.

Exclusion Criteria

• patient not willing to participate 2.
• significant cardiac, hepatic renal dysfunction 3.
• allergy to study drugs 4.
• Patient with a history of chronic use of sedatives or analgesics especially opioids and gabapentinoids 5.
• patients requiring post operative ventilatory support.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Preoperative anxiety and sedation	From time in preoperative room till 24hour of surgery
2.Quality of recovery (QoR 15 score)	From time in preoperative room till 24hour of surgery

Secondary Outcome Measures

Name	Time	Method
1. Induction dosage of propofol	2.Perioperative haemodynamic effects

Trial Locations

Locations (1)

All India Institute of Medical Science, Rishikesh; 🇮🇳 Dehradun, UTTARANCHAL, India

All India Institute of Medical Science, Rishikesh

🇮🇳Dehradun, UTTARANCHAL, India

Manasmita Dalai

Principal investigator

9438811991

manasmita.bini@gmail.com