Comparative evaluation of premedication with oral Melatonin versus Pregabalin for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation.

Comparative evaluation of premedication with oral Melatonin versus Pregabalin for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061064

Enrollment

150

Registered

2024-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis Health Condition 2: H701- Chronic mastoiditis Health Condition 3: K429- Umbilical hernia without obstruction or gangrene

Interventions

Intervention1: Comparative evaluation of premedication with oral melatonin versus pregabalin for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation: Patients in gro

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of 18-65 years of age posted for elective surgeries under general anaesthesia. American Society of Anaesthesiologists(ASA) class I-II.

Exclusion criteria

Exclusion criteria: 1.Patients posted for emergency surgeries or hemodynamically unstable patients. 2.ASA III or IV patients 3.Patients with mallampati class III OR IV. 4.Patients diagnosed with sleep disorders. 5.Patients already taking sedatives,antipsychotics,anxiolytics,antiepileptic medications. 6.Pregnant or lactating patients. 7.Patient with known allergy to any of the study drug.

Design outcomes

Primary

Measure	Time frame
Primary outcome is to compare the efficacy of oral melatonin versus pregabalin in attenuation of hemodynamic stress response to laryngoscopy & endotracheal intubationTimepoint: Hemodynamic parameters will be noted at the time of administration of study drug followed by every 30 minutes till 120 minutes of administration of drug then before laryngoscopy & endotracheal intubation after endotracheal intubation & then every minute till 10 minutes of endotracheal intubation.	—

Measure

Time frame

Primary outcome is to compare the efficacy of oral melatonin versus pregabalin in attenuation of hemodynamic stress response to laryngoscopy & endotracheal intubationTimepoint: Hemodynamic parameters will be noted at the time of administration of study drug followed by every 30 minutes till 120 minutes of administration of drug then before laryngoscopy & endotracheal intubation after endotracheal intubation & then every minute till 10 minutes of endotracheal intubation.

—

Secondary

Measure	Time frame
Secondary outcome will be measured as effect of premedication with oral melatonin versus pregabalin to allay the preoperative anxiety using VAS-A scale & to study any side effect associated with the study drugsTimepoint: Preoperative anxiety will be noted using VAS-A scale at the time of administration of study drug & after 120 minutes of administration of study drug	—

Countries

India

Contacts

Public ContactDr Shikha Walia

Dayanand Medical College and Hospital

shikhawalia18@gmail.com8437046976

Outcome results

None listed

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