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CTRI Number  CTRI/2019/05/018869 [Registered on: 01/05/2019] Trial Registered Prospectively
Last Modified On: 17/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparision of perioperative hemodynamic stability with Amlodipine and Telmisartan during laparoscopic cholecystectomy in hypertensive patients  
Scientific Title of Study   A comparision of perioperative hemodynamic stability with Amlodipine and Telmisartan during laparoscopic cholecystectomy in known hypertensive patients  
Trial Acronym  POTALAPCHOLE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mandeep Manohar Harison Madia 
Designation  Junior Resident 
Affiliation  Institute of Medical Sciences Banaras Hindu University  
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone    
Fax    
Email  harisonmadia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ram Badan Ram 
Designation  Professor 
Affiliation  Institute of Medical Sciences Banaras Hindu University  
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone    
Fax    
Email  rambadan.vns@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mandeep Manohar Harison Madia 
Designation  Junior Resident 
Affiliation  Institute of Medical Sciences Banaras Hindu University  
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University


UTTAR PRADESH
221005
India 
Phone    
Fax    
Email  harisonmadia@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 
 
Primary Sponsor  
Name  Insititute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 
Address  Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varansi Uttar Prdesh INDIA 221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mandeep Manohar Harison Madia  Department of Anaesthesiology, Institute of Medical Sciences, Sir Sundar Lal Hospital  Banaras Hindu University
Varanasi
UTTAR PRADESH 
9899465741

harisonmadia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Faculty of Medicine, Insititute of Medical Sciences, Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Amlodipine  Patients taking Amlodipine 5mg per oral once daily for Hypertension for last 7 days prior to Laproscopic Cholecystectomy 
Intervention  Telmisartan  Patients taking Telmisartan 40mg per oral once daily for Hypertension for last 7 days prior to Laproscopic Cholecystectomy 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  (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
 
 
ExclusionCriteria 
Details  (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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Better Hemodynamic Control  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
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2019 
Date of Study Completion (India) 28/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1.Pelosi P, Foti G, Cereda M, Vicardi P, et al. Effects of carbon dioxide insufflation for laparoscopic cholecystectomy on the respiratory system. Anaesthesia. 1996;51:7449. 2.Cunningham AJ, Brull SJ. Laparoscopic cholecyst-ectomy: anesthetic implications. Anesth Analg 1993;76:1120–33. 3.OMalley C, Cunningham AJ. Physiologic changes during laparoscopy. Anesthesiol Clin N Am. 2001;19(1):1–19. 4.I-gel user guide. 2007. http:/www.i-gel.com. -i-gel instruction manual. 5.Brimacombe J, Keller C. The ProSeal laryngeal mask airway: a randomized, crossover study with the standard laryngeal mask airway in paralyzed, anesthetized patients. Anesthesiology 2000;93:104–9. 6. Dumont L, Mattys M, Mardirosoff C, et al. Changes in pulmonary mechanics during laparoscopic gastroplasty in the morbidly obese patient. ActaAnaesthesiol Scand 1997;41:408–13.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This randomized prospective study will be carried out on 60 adult patients of ASA physical status II and III, scheduled for laparascopic surgeries. After the approval by the Institutional Ethical Committee, written informed consent will be obtained from all the patients before being included in the study.They will be randomly allocated to following groups of  30 each:

•                      Group  A: patients taking amlodipine as antihypertensive medication

•                      Group  B:  Patients taking  telmisartan as antihypertensive medication

All patients will receive Tab.Alprazolam 0.25mg orally, Tab.Ranitidine 150mg and Tab. Metaclopramide 10mg on the night before surgery and 2 hrs prior to surgery. Morrning dose of antihypertensive medication is given. Before arriving at the operation room an18-gauge peripheral venous cannula will be inserted and all patients will be preloaded with 500ml of Lactated Ringer solution. Patients will recieve Inj.midazolam 30mcg/kg.   In the O.R. base line readings of  Heart Rate(HR) , Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP), Oxygen Saturation(Sa02), and  End Tidal CO2(ETCO) will be measured.  Thereafter measurements of HR, SBP, DBP, MAP, ETCO2 will be taken at intervals of 1, 5 and 10 minutes will be recorded. Patients will be induced with 1% of Inj. Propofol 2mg/kg and depth of anesthesia will be monitored by loss of  following verbal commands. Inj. Vecuronium 0.1mg/kg will be administered. After mask ventilation for three minutes, the appropriate sized airway device will be inserted. Effective ventilation with device wil be defined as a square wave capnogragh trace and bilateral chest movements on manual ventilation. Patients will be maintained with 33% of oxygen in nitrous oxide, isoflurane and intermittent dose of  vecuronium . Perioperative analgesia will be provided with Inj Fentanyl 2 mcg/kg. The tidal volume and respiratory frequency will be adjusted and intermittent positive pressure ventilation (IPPV) will be continued by mechanical ventilator to maintain end tidal carbon dioxide level between 35-45 mm Hg. Pneumoperitonium will be created by insufflation of carbon dioxide and operation table will be tilted 15 degree reverse trendelenburg position.

Intra abdominal pressure will not be not allowed to exceed 14 mm Hg throughout the surgery. Any regurgitation of fluid through the gastric channel or airway tube will be noted.

Heart rate(HR), non-invasive Systolic blood pressure(SBP), Diastolic Blood pressure(DBP), Mean arterial blood pressure (MAP), oxygen saturation (SpO2), end tidal carbon dioxide(EtCO2) will be recorded at 1,5 and 10 minutes after insertion of device. After pneumoperitonium at 5,10,15,30,45,60,90 and 120  minutes and just  after removal of device. At the end of surgery residual neuromuscular block will be reversed with appropriate dose of Inj.neostigmine and Inj. glycopyrrolate intravenously. After reversal patients will be monitored in the post anesthesia care area.

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

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


 
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