Skip to content

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

Effect of different doses of oral melatonin as a premedication for attenuation of intubation response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032123
Enrollment
80
Registered
2021-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Tablet Melatonin 6 mg, tablet Melatonin 9 mg: Single dose of either tablet Melatonin 6 mg or tablet Melatonin 9 mg will be given orally 2 hours prior to intubation with sips of water t

Sponsors

Reshma B M
Lead Sponsor
DR M SALIM IQBAL
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1.To assess the level of sedation and anxiety scores before induction of anaesthesia. 2. To assess the side effects like nausea and vomiting in postoperative period 3. To assess hemodynamic response to extubation. Timepoint: 1.To assess the level of sedation and anxiety scores before induction of anaesthesia. 2. To assess the side effects like nausea and vomiting in postoperative period 3. To assess hemodynamic response to extubation.

Countries

India

Contacts

Public ContactReshma B M

Dr B.R. Ambedkar medical college and hospital

lucky3276@gmail.com8892019120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026