Study comparing melatonin and pregabalin tablets to control blood pressure and heart rate during anaesthesia for head and neck surgery

A Prospective Randomized Comparative Study For Evaluation Of Clinical Efficacy Of Oral Melatonin VS Oral Pregabalin Used As Premedication For Attenuation Of Hemodynamic Response To Laryngoscopy And Endotracheal Intubation In Patients Undergoing Head And Neck Surgery Under General Anaesthesia. - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099857

Enrollment

Registered

2025-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: H719- Unspecified cholesteatoma

Interventions

Intervention1: Oral melatonin, Oral Pregabalin and oral placebo given to patients 2hours before surgery.: Ninety patients are randomly allocated into three groups to receive oral melatonin 6 mg, oral

Eligibility

Inclusion criteria

Inclusion criteria: 1.(ASA) Grade I and II 2.Age: from18 to 60 years. 3.Patients of either sex 4.Patients planned for Elective surgery receiving general anesthesia requiring tracheal intubation. 5.Surgery duration: 30 minutes to 2 hrs

Exclusion criteria

Exclusion criteria: 1. Patient Refusal 2. Patients with difficult airway MP grade 3 and 4. 3.Patient on Antidepressant and Anxiolytics. 4. Patients with coexisting systemic illness like respiratory and cardiovascular diseases, increased intracranial pressure. 5. Increased risk for preoperative aspiration of gastric contents (patients nil per oral not less than 6 hrs.).

Design outcomes

Primary

Measure	Time frame
Attenuation of hemodynamic response to laryngoscopy and endotracheal intubation by oral melatonin and oral pregabalin used as premedication. 2. Requirement of induction dose of injection propofol. Timepoint: Till 2 hours postoperatively	—

Secondary

Measure	Time frame
1. To find out if any adverse event occurs in patients receiving oral melatonin. 2. To find out if any adverse event occurs in patients receiving oral pregabalin. 3. Post-operative recovery profile.Timepoint: Till 2 hour postoperatively	—

Countries

India

Contacts

Public ContactCharu Singh

Lala Lajpat Rai Memorial Medical College Meerut

ravi.agrawalravi@gmail.com9520531558

Outcome results

None listed

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