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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  
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 
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  
Status 
Not Applicable 
 
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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