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
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/03/032123
- Lead Sponsor
- Reshma B M
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. Patients undergoing elective surgeries under general anaesthesia
2. Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) 1 and 2
Exclusion Criteria
1. 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.
7. Patients with severe cardiac, renal or hepatic disease.
8. Pregnancy and lactation.
9. Patients on hypnotics, sedatives, anxiolytics, anti-epileptics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of oral melatonin 6mg compared with 9mg in attenuating <br/ ><br>the blood pressure (BP) and heart rate (HR) following laryngoscopy and <br/ ><br>intubation. <br/ ><br>Timepoint: Baseline, every minute for <br/ ><br>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 <br/ ><br>anaesthesia. <br/ ><br>2. To assess the side effects like nausea and vomiting in postoperative period <br/ ><br>3. To assess hemodynamic response to extubation. <br/ ><br>Timepoint: 1.To assess the level of sedation and anxiety scores before induction of <br/ ><br>anaesthesia. <br/ ><br>2. To assess the side effects like nausea and vomiting in postoperative period <br/ ><br>3. To assess hemodynamic response to extubation. <br/ ><br>