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临床试验/CTRI/2019/05/018869
CTRI/2019/05/018869已完成不适用

A comparision of perioperative hemodynamic stability with Amlodipine and Telmisartan during laparoscopic cholecystectomy in known hypertensive patients

Insititute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Telmisartan is better in controlling hemodynamics changes during laparoscopic cholecystectomy in hypertensive patients

研究概览

简要总结

This randomized prospective study will becarried out on 60 adult patients of ASA physical status II and III, scheduledfor laparascopic surgeries. After the approval by the Institutional EthicalCommittee, written informed consent will be obtained from all the patientsbefore being included in the study.They will be randomly allocated to followinggroups of  30 each:

•                     Group  A: patients takingamlodipine as antihypertensive medication

•                     Group  B:  Patients taking  telmisartan as antihypertensive medication

All patients will receive Tab.Alprazolam 0.25mg orally, Tab.Ranitidine150mg and Tab. Metaclopramide 10mg on the night before surgery and 2 hrs priorto surgery. Morrning dose of antihypertensive medication is given. Beforearriving at the operation room an18-gauge peripheral venous cannula will beinserted and all patients will be preloaded with 500ml of Lactated Ringersolution. Patients will recieve Inj.midazolam 30mcg/kg.   In the O.R. base line readings of  Heart Rate(HR) , Systolic BloodPressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP),Oxygen Saturation(Sa02), and  End TidalCO2(ETCO) will be measured.  Thereaftermeasurements of HR, SBP, DBP, MAP, ETCO2 will be taken at intervalsof 1, 5 and 10 minutes will be recorded. Patients will be induced with 1% ofInj. Propofol 2mg/kg and depth of anesthesia will be monitored by loss of  following verbal commands. Inj. Vecuronium0.1mg/kg will be administered. After mask ventilation for three minutes, theappropriate sized airway device will be inserted. Effective ventilation withdevice wil be defined as a square wave capnogragh trace and bilateral chestmovements on manual ventilation. Patients will be maintained with 33% of oxygenin nitrous oxide, isoflurane and intermittent dose of  vecuronium . Perioperative analgesia will beprovided with Inj Fentanyl 2 mcg/kg. The tidal volume and respiratory frequencywill be adjusted and intermittent positive pressure ventilation (IPPV) will becontinued by mechanical ventilator to maintain end tidal carbon dioxide levelbetween 35-45 mm Hg. Pneumoperitonium will be created by insufflation of carbondioxide and operation table will be tilted 15 degree reverse trendelenburgposition.

Intra abdominal pressure will not be not allowed to exceed 14 mmHg throughout the surgery. Any regurgitation of fluid through the gastricchannel or airway tube will be noted.

Heart rate(HR), non-invasive Systolic blood pressure(SBP), DiastolicBlood pressure(DBP), Mean arterial blood pressure (MAP), oxygen saturation (SpO2),end tidal carbon dioxide(EtCO2) will be recorded at 1,5 and 10 minutesafter insertion of device. After pneumoperitonium at 5,10,15,30,45,60,90 and120  minutes and just  after removal of device. At the end ofsurgery residual neuromuscular block will be reversed with appropriate dose ofInj.neostigmine and Inj. glycopyrrolate intravenously. After reversal patientswill be monitored in the post anesthesia care area.

Complications such as incidence of any airway complications caused by supraglottic deviceswill be managed accordingly.

The study will end after 1 month after all data has been obtained.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • (1)ASA II or ASA III patients scheduled for elective laparoscopic surgery, with I-gel as airway device.
  • (2)patients aged between 40 and 70 years of either sex.

排除标准

  • (1)Patients with upper respiratory tract infection, restrictive or obstructive lung disease (2)Anticipated difficult airway with mouth opening less than 2 cm (3)Hiatus hernia, Gastro-esophageal reflux disease (4)History of allergy to silicone and elastomer.

结局指标

主要结局

Telmisartan is better in controlling hemodynamics changes during laparoscopic cholecystectomy in hypertensive patients

时间窗: PREOP | INTRAOP | AFTER INSERTION | 1MIN | 3MIN | 5MIN | 10MIN | AFTER | PNEUMOPERITONIUM | 5 MIN | 10 MIN | 15 MIN | 30 MIN | 45 MIN | 60 MIN | 90 MIN | 120 MIN | AFTER REMOVAL

次要结局

  • Better Hemodynamic Control(PREOP)

研究者

发起方
Insititute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
申办方类型
Government medical college

研究点 (1)

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