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
|
|
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
|
|
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. |