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临床试验/CTRI/2022/08/044818
CTRI/2022/08/044818尚未招募不适用

COMPARATIVE OBSERVATIONAL PROSPECTIVE RANDOMIZED STUDY TO DETERMINE THE EFFECT OF CLONIDINE AS AN ADJUNCT TO INDUCTION AGENTS IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING SURGERY

Rahul Sarkar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Hemodynamic parameters (SBP, DBP, MAP, HR)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Hemodynamic parameters (SBP, DBP, MAP, HR)

时间窗: Baseline, Before induction, Before intubation, 5 minutes after intubation, End of Surgery

次要结局

  • Adverse effects(During entire surgery period)

研究者

发起方
Rahul Sarkar
申办方类型
Other [SELF (RAHUL SARKAR)]

研究点 (1)

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