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CTRI Number  CTRI/2024/03/063453 [Registered on: 01/03/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the effect of intraoperative intravenous lidocaine and dexmedetomidine infusions on post-operative pain and recovery profile in spine surgeries 
Scientific Title of Study   Comparison of the effect of intraoperative intravenous lidocaine and dexmedetomidine infusions on post-operative pain and recovery profile in spine surgeries – A Randomized non-inferiority trial. 
Trial Acronym  -- 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MOHAMMED 
Designation  JUNIOR RESIDENT 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY 
Address  JIPMER Campus Road, JIPMER Campus, Dhanvantari Nagar, Puducherry, 605006 Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  8252341058  
Fax    
Email  mohammedjolam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gnanasekaran S 
Designation  Associate professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY 
Address  JIPMER Campus Road, JIPMER Campus, Dhanvantari Nagar, Puducherry, 605006 Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9487188275  
Fax    
Email  gnansdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gnanasekaran S 
Designation  Associate professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY 
Address  JIPMER Campus Road, JIPMER Campus, Dhanvantari Nagar, Puducherry, 605006 Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9487188275  
Fax    
Email  gnansdr@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research,PUDUCHERRY 
 
Primary Sponsor  
Name  Jawaharlal institute of Postgraduate Medical Education and Research 
Address  Gorimedu Dhanvatri nagar 605006 
Type of Sponsor  Research institution and hospital 
 
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 MOHAMMED  Jawaharlal Institute of Post-Graduate Medical Education and Research  Department of Anaesthesiology and CC, Dhanwantari Nagar, Pondicherry 605006
Pondicherry
PONDICHERRY 		 8252341058

mohammedjolam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlalinstitute ofpostgraduatemedicaleducationandresearchethicscommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G959||Disease of spinal cord, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  injection dexmedetomedine  the above menioned drug when used will be given as intravenous bolus of 0.5 µg/kg (0.125 ml/kg) over a period of 10 minutes and maintanenace of 0.2 µg/kg/hour  
Comparator Agent  injection lidocaine  the above mentioned drug will be given intravenous bolus of 1.5 mg/kg(according to ideal body weight) over a period of 10 minutes (0.15 ml/kg) and 1.5 mg/kg/hour(0.15 ml/kg/hr)( according to ideal body weight)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  a. Inclusion criteria:
Patients scheduled for elective spine surgeries (one or two vertebrae levels) under General anesthesia
1. Adult patients aged 18-70years belonging to either sex.
2. American society of Anesthesiologists (ASA) physical status 1-2
 
 
ExclusionCriteria 
Details  b. Exclusion criteria:
1.Allergy to any of the drugs used in the study i.e., lidocaine and dexmedetomidine.
2.Patients having impaired hepatic or renal function or ischemic heart disease.
3.Patients with conduction blocks or arrhythmias.
4.Patients with psychiatric illness and seizure disorder.
5.Patients who are on opioid supplements for pain management within two weeks of surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of 24 hours post-operative morphine consumption between the groups using patient-controlled analgesia  Postoperatively all patients will have access to PCA pump for 24 hours to receive a bolus of 1 mg morphine with a lock-out interval of 15 minutes without background infusion. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of
1 Intraoperative fentanyl requirement between the groups
2 Hemodynamic parameters MAP & HR between groups
3 Time of emergence between groups
4 Pain at postoperative periods of 1 6 12 24 48 hours using NRS pain scale between groups at rest & during movement
5 Opioid related side effects postoperative nausea & vomiting pruritus sedation using Richmond Agitation Sedation scale
6 Recovery characteristics between groups using Quality of Recovery 15 QoR15 score at the end of 48 hours in the postoperative period
 		 1 6 12 24 48 hours pain score in postoperative period 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 2 
Date of First Enrollment (India)   08/01/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Comparison of the effect of intraoperative intravenous lidocaine and dexmedetomidine infusions on post-operative pain and recovery profile in spine surgeries – A Randomized  non-inferiority trial. 
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