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

Phase 3

Active, not recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2020/10/028682
• Lead Sponsor: Paras Hospital

Brief Summary

This study is a prospective, randomized, double blinded, multiple arm, parallel study trial comparing the safety and efficacy of oral melatonin 6 mg and oral clonidine 0.2 mg as premedication in attenuation of hemodynamic response to direct laryngoscopy and endotracheal intubation. The total sample size will be 120 patients of ASA grade I and II. The primary outcome measures will be stability of hemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure, rate pressure product, and oxygen saturation, to be measured 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.  The secondary outcomes will be requirement of propofol dose at the time of induction and rescue doses during surgery, and volume of inhalational anesthetic agent every 15 minutes interval during surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-30
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

• 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.
• Patients receiving treatment for any cardiac illness, pregnancy, renal disease, liver disease, morbid obesity, bleeding disorder.
• Patients on anti-hypertensives, oral hypoglycemics, anti-depressants, anti-convulsants, anti-psychotics, and birth control pills.
• Pregnant and lactating females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
heart rate, systolic blood pressure, diastolic blood pressure, mean blood pressure, rate pressure product, and oxygen saturation.	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 Outcome Measures

Name	Time	Method
propofol dose	at the time of induction
volume of inhalational anesthetic agent	Every 15 minutes during surgery

Trial Locations

Locations (1)

Paras Hospital; 🇮🇳 Gurgaon, HARYANA, India

Paras Hospital

🇮🇳Gurgaon, HARYANA, India

Dr Ashish Gupta

Principal investigator

8683054779

ashishg19995@gmail.com