Skip to content

A clinical trial to study the effect of oral melatonin versus pregabalin in decreasing hemodynamic response (heart rate, blood pressure) to laryngoscopy and endotracheal intubation.

A comparative study of oral melatonin versus pregabalin for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation: A prospective randomized open label study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/073110
Enrollment
60
Registered
2024-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Tablet melatonin 3 mg two tablets given orally with sips of water two hours before intubation Control Intervention1: Tablet Pregabalin: Tablet pregabalin 75 mg two tab

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All Patients aged 18 years to 65 years 2. Patients with American Society of Anaesthesiologists (ASA) physical status I to II 3. Patients with Mallampati grade (MPG) I to II

Exclusion criteria

Exclusion criteria: 1. Patients with sleep disorders 2. Patients who are already on study drugs 3. Patients with known allergy to study drugs 4. BMI more than 30 kg/m2 5. Patients with anticipated difficult intubation 6. Duration of surgical procedure exceeding 4 hours 7. Pregnant and lactating women 8. Patients not willing to give consent

Design outcomes

Primary

MeasureTime frame
To study changes in hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressureTimepoint: Before administering study drugs (T0), before induction of anaesthesia (T1), Just before intubation (T2), 1 minute(T3), 3 minutes(T4), 6 minutes (T5), 9 minutes (T6) and 15 minutes (T7) after intubation

Secondary

MeasureTime frame
1. To study the induction dose of IV propofol between the two groups 2. Patient sedation scores using Observers assessment of Alertness/Sedation scores(OASS) 3. Intraoperative requirements of IV fentanylTimepoint: Sedation scores just before induction of general anaesthesia (S0), 15 minutes (S1), 30 minutes (S2), 60 minutes (S3) after extubation

Countries

India

Contacts

Public ContactDr M Madhusudhan

Sri Venkateswara Institute of Medical Sciences

drmadhu37@gmail.com9493547723

Outcome results

None listed

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