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

Completed

Conditions: Essential (primary) hypertension,

Registration Number: CTRI/2019/05/018869

Lead Sponsor: Insititute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh

Brief Summary: 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:

â€¢                     Group A: patients takingamlodipine as antihypertensive medication

â€¢                     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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Better Hemodynamic Control	PREOP

Trial Locations

Locations (1): Department of Anaesthesiology, Institute of Medical Sciences, Sir Sundar Lal Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Department of Anaesthesiology, Institute of Medical Sciences, Sir Sundar Lal Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Mandeep Manohar Harison Madia
Principal investigator
9899465741
harisonmadia@gmail.com