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CTRI Number  CTRI/2024/12/078106 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dexamethasone and Dexmedetomidine combination for reducing pain and opioid consumption in spine surgery 
Scientific Title of Study   To Compare The Opioid Sparing Effects Of Combination Of Dexamethasone And Dexmedetomidine Vs Dexamethasone In Patients Undergoing Lumbar Spine Surgery: A Prospective Double Blind Randomised Placebo Controlled Trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parin Lalwani  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room no 1 Porta Cabin, Fourth Floor Teaching Block, AIIMS

South
DELHI
110029
India 
Phone  9650533388  
Fax    
Email  drparinlalwani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Parin Lalwani  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, Room no 1 Porta Cabin, Fourth Floor Teaching Block, AIIMS

South
DELHI
110029
India 
Phone  9650533388  
Fax    
Email  drparinlalwani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varshini G 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care. AIIMS

South
DELHI
110029
India 
Phone  9741323342  
Fax    
Email  varshini897@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, New Delhi 
Address  Ansari Nagar East, New Delhi, 110029 
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 
Parin Lalwani   All India institute of medical sciences New Delhi   Orthopaedics operations room, first floor, main building above emergency, All india institute of medical sciences New Delhi Sri Aurobindo Marg Ansari nagar New Delhi 110049
South
DELHI 
9650533388

drparinlalwani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for postgraduate research, All India Institute of Medical Sciences, New Delhi.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone 0.2 mg/kg Dexmedetomidine 0.5-0.7 mcg/kg/hour  Intravenous dexamethasone will be given 1 hour before surgery, intravenous Dexmedetomidine infusion will be started after induction of anaesthesia and positioning of patient in prone for conduct of spine surgery and continued till closure of muscle layer. 
Comparator Agent  Dexamethasone 0.2 mg/kg, Placebo 50ml of 0.9% normal saline.  Intravenous dexamethasone will be given 1 hour before surgery, intravenous placebo of 0.9% normal saline infusion will be started after prone position and continued till closure of muscle layer. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status I and II posted for elective lumbar spine surgery of 1 or 2 levels. 
 
ExclusionCriteria 
Details  1. Patients refusal
2. Patients belonging to class: ASA physical status III and IV
3. Limitations in understanding use of PCA pump
4. Patients with a preoperative heart rate less than 60 beats per minute
5. Chronic analgesic or steroid use
6. Presence of significant dysfunction like cardiovascular, neurological, respiratory, hepatic or renal
7. History of uncontrolled diabetes mellitus
8. Patients having history of drug abuse
9. Known allergy to drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperative   Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperative  
 
Secondary Outcome  
Outcome  TimePoints 
Time for first analgesic requirement  24 hours postoperative  
Pain scores at rest and during movement at 0 min, 1 hour, 4 hours, 8 hours, 12 hours, 24 hours postoperative   0 minute, 1,4,8,12,24 hours postoperative  
Postoperative nausea and vomiting  0, 15, 30 minutes, 1,2,4,8,12,24 hours postoperative  
Hyperglycaemic state of patient till 24 hours after surgery  1 hour before surgery, 1 hour after surgery, 8th hourly till 24 hours postoperative  
Wound healing/infection at 1 week  7 days postoperative  
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   21/12/2024 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Adults commonly undergo lumbar spine surgery for conditions such as fractures, herniations, tumors, spinal stenosis, degenerative disc disease, and spondylolisthesis. Surgical spine procedures can be one of the most painful operative treatments that a patient undergoes due to the extensive tissue manipulation, muscle retraction, and the substantial number of implants required for adequate fixation. These procedures necessitate significant analgesia for adequate control of pain. Traditionally postoperative pain is treated with opioids but they are associated with range of adverse effects. Recently efforts have been promoted to reduce opioid consumption and their associated adverse effects like nausea, vomiting, urinary retention, constipation, respiratory depression.


Opioid alternatives include acetaminophen, NSAIDs, COX-2 specific inhibitors, gabapentin, local anaesthetics, dexamethasone, alpha 2 agonists and ketamine.

In our study we are using combination of above 2 drugs for opioid sparing effect. They are dexamethasone and Dexmedetomidine.


Dexamethasone (Dexa) is a glucocorticoid with a well-established analgesic and anti- emetic properties and suppresses the tissue levels of bradykinin. Inhibition of phospholipase which plays an essential role in the inflammatory chain reaction of both cyclooygenase and lipooxygenase pathway majorly contribute towards analgesic effect of dexamethasone.


Dexmedetomidine (Dex) make up the alpha-2 adrenergic receptor agonists which have been widely used as a target for medical conditions such as pain disorders, hypertension, ADHD (attention deficit hyperactivity disorder), and illicit drug use withdrawal symptoms. In recent years, alpha-2 agonists have been used as adjuncts for sedation and anesthetic use while partially blocking withdrawal symptoms in chronic opioid user. Dexmedetomidine activates α2-AR in the spinal cord reducing transmission of nociceptive signals like substance P. It has significant opioid sparing effect and is useful in intractable neuropathic pain. This advantage has made these drugs emerge as a new and effective analgesic for surgical spine patients.



 
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