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A study to compare how well two different dosages of oral melatonin (6mg and 9mg) attenuate rise in blood pressure and heart rate in response to laryngoscopy and intubation when given 1 hour before administration of general anaesthesia.

A study to compare the effects of two different dosages of oral melatonin 1 hour before induction for attenuation of haemodynamic response to endotracheal intubation under general anaesthesia. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078260
Enrollment
70
Registered
2024-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: H958- Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified

Interventions

Intervention1: Melatonin: Drug: Melatonin Route: Oral Dose: 6mg Frequency: Once, 60 minutes before induction. Control Intervention1: Melatonin: Drug: Melatonin Route: Oral Dose: 9mg Frequency: Once,

Sponsors

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients willing to sign informed consent. Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II. Patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia. Patient having mouth opening more than 3cm Patient with Malampatti grade 1 and 2

Exclusion criteria

Exclusion criteria: Patients unwilling to participate in the study. Patients having contraindication to endotracheal intubation/general anaesthesia. Patient having mouth opening less than 3cm. Patient with Mallampati grade 3 and 4 body mass index (BMI) more than 30 kg per m square. patients taking anxiolytics, sedatives, antipsychotic, or antiepileptic drugs. Patients having a sleep disorder, hiatus hernia, gastroesophageal reflux, known allergy to melatonin, and a known case of coronary artery disease. Patients with ischemic and valvular heart disease.

Design outcomes

Primary

MeasureTime frame
To study attenuation in stress repsonse and haemodynamics and during intubation and laryngoscopyTimepoint: Baseline 60 mins after drug administration Just after induction Just after laryngoscopy and intubation At 1 minute At 3 minutes At 5 minutes At 10 minutes At 15 minutes—

Secondary

MeasureTime frame
To study post op sedation score after extubation or any side effects upto 120 minutes.Timepoint: Ramsey sedation scale(RSS) will be used to assess post op sedation score at 15, 30, 60, 90 and 120 minutes after extubation.—

Countries

India

Contacts

Public ContactDr Dinesh Chauhan

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

drdinesh77@gmail.com9099014672

Outcome results

None listed

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