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CTRI Number  CTRI/2022/09/046008 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 28/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate effect of dexmedetomidine versus lidocaine on post operative analgesia in spine surgery 
Scientific Title of Study   A prospective randomised comparative double blinded study to evaluate the effect of dexmedetomidine versus lidocaine infusion in spine surgery on post operative analgesia at SMS Medical College and attached group of hospitals, Jaipur during 2021-2023. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr neelu sharma 
Designation  associate professor 
Affiliation  SMS Medical College 
Address  Department of Anaesthesiology, 2nd floor Dhanvantri building, SMS Medical College, jaipur
Department of Anaesthesiology, 2nd floor Dhanvantri building, SMS Medical College, jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9782480455  
Fax    
Email  drneelu13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr neelu sharma 
Designation  associate professor 
Affiliation  SMS Medical College 
Address  Department of Anaesthesiology, 2nd floor Dhanvantri building, SMS Medical College, jaipur
Department of Anaesthesiology, 2nd floor Dhanvantri building, SMS Medical College, jaipur

RAJASTHAN
302004
India 
Phone  9782480455  
Fax    
Email  drneelu13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Himani Kaushik 
Designation  Junior Resident 
Affiliation  SMS Medical College 
Address  Department of Anaesthesiology, 2nd floor Dhanvantri building, SMS Medical College, jaipur
Department of Anaesthesiology, 2nd floor Dhanvantri building, SMS Medical College, jaipur
Jaipur
RAJASTHAN
302004
India 
Phone  9461677638  
Fax    
Email  dochimanikaushik@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, SMS Medical College,JLN Marg, jaipur 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  SMS Medical college,jaipur,302004 
Type of Sponsor  Government 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 
Dr Neelu Sharma  SMS Medical college and Hospital,jaipur  Department of Anaesthesiology,2nd Floor Dhanvantri building,Jaipur, 302004
Jaipur
RAJASTHAN 		 9782480455

drneelu13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S.M.S MEDICAL COLLEGE & ATTACHED HOSPITAL,JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  Infusion of Dexmedetomidine 0.3mcg/kg/hr given via intravenous route intraoperatively. 
Comparator Agent  Lidocaine  Infusion lidocaine at the rate of 0.3mg/kg/hr given via intravenous route intraoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient undergoing spine surgery with duration within 3 hrs.
ASA Grade I&II.
Weight 40-80 kg.
written and informed consent. 
 
ExclusionCriteria 
Details  Patients with a known history of hepatic disese, renal dysfunction, hypertension, atrioventricular block.
history of hypersensitivity to study medication
Patients having chronic pain or concomittantly taking clonidine, methyldopa, beta blockers, benzodiazapines.
Patients having unstable Haemodynamic parameters. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean duration of requirement of first rescue analgesia in post operative period.  immediate post op, after 1hr, 4hr,8hr,12hr,till 24 hr. 
 
Secondary Outcome  
Outcome  TimePoints 
mean number of doses of total rescue analgesia required.  just after surgery, at 1hr, 4hr,8hr,12hr till 24hr. 
haemodynamic parameters(Mean HR, Mean SBP, Mean DBP, Mean BP,SPO2  intraoperative(baseline, at begining of infusion, at 5 min,10 min,15 minthen every 15 min till 180 min), and postoperative (immediate,at 1hr, 4hr,8hr,12 hr,24 hr). 
Median Ramsay sedation score  postoperative period(immediate,1hr,4hr,8hr,12hr,24hr) 
Proportion of cases with any complications and side effects  postoperative period till 24 hr 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   30/09/2022 
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="3"
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   in this study we will compare the effect of  intravenous dexmedetomidine versus intravenous lidocaine in patients undergoing spine surgey on postoperative analgesia using ramsay sedation score, haemodynamic parameters. 
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