| 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
|
|
|
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
|
|
|
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. |