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A Study on Effect of Oral Melatonin and Oral Clonidine on stability of Heart rate and blood pressure during administration of general anesthesia

A Study on Effect of Oral Melatonin and Oral Clonidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Endotracheal Intubation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028682
Enrollment
120
Registered
2020-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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: Melatonin: 6 mg, oral, 60 minutes before induction of anesthesia Intervention2: Clonidine: 0.2 mg, oral, 60 minutes before induction of anesthesia Control Intervention1: Placebo: sugar

Sponsors

Paras Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients in age group of 20 to 60 years 2. ASA grade I or II 3. Elective surgery under general endotracheal anaesthesia 4. Multivariate risk index (MVRI) score less than 4

Exclusion criteria

Exclusion criteria: 1. Patients less than 20 and more than 60 years of age 2. ASA grade III or IV 3. Anticipated difficult intubation 4. Body Mass Index (BMI) greater than 30 kilograms per meter square 5. Modified Mallampatti grade III or IV 6. MVRI equal to or more than 4 7. Emergency surgeries 8. Patient’s refusal to participate in the study 9. Patient receiving treatment with either of the study drug that is melatonin or clonidine; or having any known allergy to these drugs. 10. Patients receiving treatment for any cardiac illness, pregnancy, renal disease, liver disease, morbid obesity, bleeding disorder. 11. Patients on anti-hypertensives, oral hypoglycemics, anti-depressants, anti-convulsants, anti-psychotics, and birth control pills. 12. Pregnant and lactating females.

Design outcomes

Primary

MeasureTime frame
heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure, rate pressure product, and oxygen saturation.Timepoint: before drug administration, after 30 minutes of drug administration, before induction, immediately after intubation (0 minute), and 1,2,3,5,10 minutes following endotracheal intubation.

Secondary

MeasureTime frame
propofol doseTimepoint: at the time of induction rescue doses during surgery;volume of inhalational anesthetic agentTimepoint: Every 15 minutes during surgery

Countries

India

Contacts

Public ContactDr Apra Singh Rai

Paras Hospital

2606dks@gmail.com

Outcome results

None listed

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