A STUDY BETWEEN 2 GROUPS TO DETERMINE THE EFFECT OF CLONIDINE DRUG IN REQUIREMENTS OF INDUCTION AGENT FOR PATIENTS UNDERGOING CABG SURGERY.

Not yet recruiting

• Conditions: Acute myocardial infarction, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2022/08/044818
• Lead Sponsor: Rahul Sarkar

Brief Summary

This Comparative Observational Prospective Randomized Study will be conducted in Department of Anesthesiology,D Y Patil University School of Medicine & Hospital, Nerul, Navi Mumbai.

1) Pre-operative evaluationHistory, PAST History, Clinical Examination, Routine investigations, Stress test, 2 D-ECHO, Coronary Angiography.2) On the day of surgery, patients will be examined. Volunteers will be allocated randomly with sealed envelop technique to 2 groups each containing forty patients each.• Group A (Clonidine) - Patients will receive i.v. clonidine as a pre-medication dose of 4 µg/kg in the OT.• Group B (Placebo) - Patients will receive IV 0.9%Normal Saline of the same volume in the OT.— NBM status will be confirmed. — Informed written consent will be taken.— Pre-operative vitals will be recorded in the form of baseline pulse and blood pressure.— After arriving in the OT monitors will be attached- Manual BP cuff, Pulse oximeter, Temperature Probe, Ecg Chest Leads.Cardio scope.Inspired air will be supplemented with oxygen at 5-6 liters/min— Vein will be canulated with appropriate intracath (16 G or 18 G) on the dorsum of hand.— Inj clonidine (4 µg/kg) will be given i.v. over 10 minutes.— Internal jugular vein will be canulated with triple lumen.— Radial artery will be canulated for intra-arterial blood pressure monitoring.— The patient will be induced with inj midazolam (0.1 mg/kg), inj fentanyl (5-10 µg/kg) and inj Vecuronium (0.1 mg/kg).The doses of Inj. propofol required will be given and any additional doses if required during the procedure will be noted.Maintenance: Sevoflurane (2% ) & Sedation Mixture (Inj. Fentanyl + Inj. Midazolam + Inj.Vecuronium)Rescue maintenance required with sevoflurane in the incremental doses 4%- 6% will be noted.The following Parameters will be Monitored intraoperatively: ECG, Pulse Oximetry, EtCO‚ IBP, CVP, Nasopharyngeal Temperature, Serial ABG, ACT.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-08-22
• Study Start: 2022-08-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• â–ª All patient giving consent â–ª Patients undergoing CABG â–ª Age 30 -65 yrs.
• â–ª Ejection fraction > 40% â–ª Body Mass Index â–ª Patients without pulmonary hypertension â–ª Patients of either sex â–ª ASA grade II & III.

Exclusion Criteria

• 1.Patients not willing to get enrolled in the study.
• 2.Age < 30 yrs and > 65 yrs 3.Ejection fraction < 40% 4.Patients with pulmonary hypertension 5.Valvular heart diseases 6.Pregnant patient 7.Patients with bronchial asthma 8.Patient on treatment with antipsychotic drugs/psychic patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodynamic parameters (SBP, DBP, MAP, HR)	Baseline, Before induction, Before intubation, 5 minutes after intubation, End of Surgery

Secondary Outcome Measures

Name	Time	Method
Adverse effects	During entire surgery period

Trial Locations

Locations (1)

D Y Patil Medical College and Hospital; 🇮🇳 Thane, MAHARASHTRA, India

D Y Patil Medical College and Hospital

🇮🇳Thane, MAHARASHTRA, India

Rahul Sarkar

Principal investigator

7219031392

rahul.sarkar.rahul123@gmail.com