| 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
|
|
|
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
|
|
|
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.
|