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CTRI Number  CTRI/2019/06/019683 [Registered on: 14/06/2019] Trial Registered Prospectively
Last Modified On: 13/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparing the effectiveness of two drugs (dexmeditomidine and clonidine) in laparoscopic cancer surgeries. 
Scientific Title of Study   A Comparative study of intravenous Dexmedetomidine and Clonidine on haemodynamic response in laparoscopic lower abdominal onco-surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRASHANT HATTI 
Designation  POSTGRADUATE 
Affiliation  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  Department of Anesthesiology, Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda road, Hombegowda nagar, Bangalore, Karnataka - 560029

Bangalore
KARNATAKA
560029
India 
Phone  968606250  
Fax    
Email  prashanthatti1225@gmil.com  
 
Details of Contact Person
Scientific Query
 
Name  V B GOWDA 
Designation  PROFESSOR 
Affiliation  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  Department of Anesthesiology, Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda road, Hombegowda nagar, Bangalore, Karnataka - 560029
Department of Anesthesiology, Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda road, Hombegowda nagar, Bangalore, Karnataka - 560029
Bangalore
KARNATAKA
560029
India 
Phone  9845259264  
Fax    
Email  vbchethana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PRASHANT HATTI 
Designation  POSTGRADUATE 
Affiliation  KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY 
Address  Department of Anesthesiology, Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda road, Hombegowda nagar, Bangalore, Karnataka - 560029

Bangalore
KARNATAKA
560029
India 
Phone  968606250  
Fax    
Email  prashanthatti1225@gmil.com  
 
Source of Monetary or Material Support  
Patients coming to the pre anaesthetic clinic of Kidwai Memorial Institute of Oncology, Bangalore  
 
Primary Sponsor  
Name  PRASHANT HATTI 
Address  Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda road, Hombegowda nagar, Bangalore, Karnataka - 560029  
Type of Sponsor  Other [] 
 
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 
Prashant Hatti  Kidwai Memorial Institute of Oncology, Bangalore.  Opertion theatre, Dept of anaesthesiology, Kidwai Memorial Institute of Oncology, Dr. M.H. Marigowda road, Hombegowda nagar, Bangalore, Karnataka - 560029
Bangalore
KARNATAKA 
96860650

prashanthatti1225@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (2) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (3) ICD-10 Condition: C543||Malignant neoplasm of fundus uteri, (4) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (5) ICD-10 Condition: C541||Malignant neoplasm of endometrium, (6) ICD-10 Condition: C561||Malignant neoplasm of right ovary, (7) ICD-10 Condition: C562||Malignant neoplasm of left ovary, (8) ICD-10 Condition: C530||Malignant neoplasm of endocervix, (9) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (10) ICD-10 Condition: C574||Malignant neoplasm of uterine adnexa, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmeditomedine or Clonidine  1 mcg/Kg intravenous before induction over a period of 15 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 – 60 years
Patients belonging to ASA Grade I and II
 
 
ExclusionCriteria 
Details  Patient refusal
Patient age below 18 years and above 65 years
Patient belonging to ASA grade III and IV
Patients on beta-blockers.
Patients with cardiac dysfunction, hepatic, renal disease.
Patients with psychiatric disorders.
Patients with allergic disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
comparing the hemodynmic responces.  during intubation, during pneumoperitonium, during extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
comparing the hemodynmic responces.  Every 5 min from intubation till pneumoperitonium, every 10 min from pneumoperitonium till extubation.  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/06/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

From the early 1970s laparoscopic procedures became well established because of its advantages like reduced post operative pain, improved cosmesis, reduced hospital stay.

Despite its advantages, laparoscopic surgeries have its own demerits due to pneumoperitoneum and positional changes. Pneumoperitoneum causes alteration in cardiorespiratory physiology like reduced thoracopulmonary compliances, reduced functional residual capacity(FRC), increased arterial pressures, increased systemic vascular resistance and pulmonary vascular resistance. Plasma catecholamines and vasopressin levels increases during pneumoperitoneum which is associated with changes in total peripheral resistance. Trendelenburg position and Carbon dioxide(CO2) causes hemodynamic stress.

Various pharmacological agents like nitroglycerine, beta blocker, magnesium sulphate and opioids are used to provide hemodynamic stability during pneumoperitoneum with their own limitations.

Alpha-2 (α2) adrenergic agonists have shown the promising result in maintaining the baseline hemodynamic parameters during laparoscopic surgeries with minimal adverse effects. Alpha-2 (α2) adrenergic agonists are useful in attenuating the hemodynamic responses produced by pneumoperitoneum. But not many studies have been done studying the comparative effect of these two drugs especially in laparoscopic onco-surgeries. Hence this study is being taken up to compare intravenous dexmedetomidine and clonidine on haemodynamic response in laparoscopic lower abdominal onco-surgeries.

 
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