| CTRI Number |
CTRI/2021/03/032319 [Registered on: 25/03/2021] Trial Registered Prospectively |
| Last Modified On: |
25/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparison of oral premedication with clonidine versus pregabalin for hemodunamic stability during laproscopic cholecystectomy under general anesthesia |
|
Scientific Title of Study
|
comparison of oral premedication with clonidine versus pregabalin for hemodunamic stability during laproscopic cholecystectomy under general anesthesia : a double blinded randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHWETA LAMANI |
| Designation |
Anaesthesia junior resident |
| Affiliation |
S Nijalingappa Medical college and Hanagal Shri Kumareshwar Hospital and Research Centre Bagalkot |
| Address |
S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 Bagalkot KARNATAKA 587102 India |
| Phone |
9980512834 |
| Fax |
|
| Email |
shwetambbs1995@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Y HULAKUND |
| Designation |
Professor and HOD Department of Anaesthesiology |
| Affiliation |
S Nijalingappa Medical college and Hanagal Shri Kumareshwar Hospital and Research Centre Bagalkot |
| Address |
Department of Anaesthesiology S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 Bagalkot KARNATAKA 587102 India |
| Phone |
9901098533 |
| Fax |
|
| Email |
hulkunds@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SHWETA LAMANI |
| Designation |
Anaesthesia junior resident |
| Affiliation |
S Nijalingappa Medical college and Hanagal Shri Kumareshwar Hospital and Research Centre Bagalkot |
| Address |
S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 Bagalkot KARNATAKA 587102 India |
| Phone |
9980512834 |
| Fax |
|
| Email |
shwetambbs1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology SNMC Navanagar Bagalkot |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa Medical College and HSK Hospital |
| Address |
S Nijalingappa Medical College and HSK Hospital Bagalkot 587102 |
| Type of Sponsor |
Private 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 |
| SHWETA LAMANI |
HSK HOSPITAL |
Department of Anaesthesia HSK hospital SNMC Navanagar Bagalkot 587102 Bagalkot KARNATAKA |
9980512834
shwetambbs1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC Institutional ethics comittee on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients will be receiving oral clonidine |
Group C includes in whom patients will be receiving oral clonidine 200mcg 60-90 minutes prior to surgery |
| Comparator Agent |
Patients will be receiving oral placebo. |
group A includes in whom patients will bereceving placebo 60-90 mins prior to surgery |
| Intervention |
Patients will be receiving oral pregabalin |
GROUP B includes in whom patients will be receiving oral pregabalin 150mg 60-90 minutes prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II
Body mass index less than or equals to 30 kg/m2
Patients undergoing Laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
Patient refusal to give consent
History of substance abuse
Patients on antihypertensives
Hepatic or renal dysfunction
Pregnant or lactating females
Anticipated difficult airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Both the drugs to be efficacious in maintaining hemodynamic stability and clonidine to be superior to pregabalin in maintaining hemodynamic stability during laparoscopic cholecystectomy |
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compared to clonidine pregabalin has better preoperative and post operative sedation. |
6 hours |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
25/03/2021 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of oral premedication with clonidine versus pregabalin for hemodynamic stability during laparoscopic cholecystectomy under general anaesthesia : A double blinded randomized control study. Laparoscopic surgeries are now a days being the standard approach for most common surgical procedures. It has gained popularity in clinical practice in view of shorter hospital stay, early ambulation, smaller incisional scar, and less compromised postoperative respiratory and gastrointestinal function. However it is associated with significant intraoperative haemodynamic changes largely due to creation of carbon-di-oxide pneumoperitoneum to facilitate the surgery. Mechanical effects of pneumoperitoneum, systemic absorption of carbon-di-oxide (CO2) causing release of catecholamines and patient positioning also contribute to various unfavourable haemodynamic responses. These surgeries are done under general anaesthesia with direct laryngoscopy for tracheal intubation which is associated with autonomic changes like tachycardia, hypertension and dysrhythmias which are usually well tolerated in ASA grade I & II patients and maybe detrimental in patients with pre-existing diseases. Clonidine is an α-2 adrenoreceptor agonist with central sympatholytic effect. Premedication with clonidine blunts the haemodynamic stress responses to direct laryngoscopy and tracheal intubation and it also stabilizes blood pressure by increasing cardiac baroreceptor reflex sensitivity. Pregabalin, a gabapentinoid compound appears to produce an inhibitory modulation of neuronal excitability particularly in neocortex, amygdala and hippocampus of CNS. It possess analgesic, anticonvulsant and anxiolytic activity by reduction of neurotransmitter glutamate, nor-adrenaline, serotonin, dopamine and substance P. The aim of the study is to compare the efficacy of oral clonidine with oral Pregabalin in maintaining hemodynamic stability during laparoscopic cholecystectomy under general anaesthesia.
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