| CTRI Number |
CTRI/2024/02/062613 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Ketamine spray versus Dexmedetomidine spray at surgical site during closure in lumbar spine fixation surgery for postoperative pain relief |
|
Scientific Title of Study
|
To compare the effect of Ketamine spray versus Dexmedetomidine spray at surgical site during closure in lumbar spine fixation surgery for postoperative pain relief - Prospective, Randomized, double blinded, placebo controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annamalaei |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care,Institute of medical sciences,BHU Varanasi Uttar pradesh 221005, India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7708731499 |
| Fax |
|
| Email |
annamallaei@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashpal singh |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical care,Institute of medical sciences,BHU Varanasi Uttar pradesh 221005, India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birju Manjhi |
| Designation |
Associate professor |
| Affiliation |
Trauma centre, BHU |
| Address |
Trauma centre
Department of Orthopaedics,
Institute of medical sciences,BHU,Varanasi, Uttar pradesh 221005, India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956949374 |
| Fax |
|
| Email |
manjhibirju@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical Sciences, Banaras hindu university |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences banaras hindu university |
| Address |
Institute of medical sciences, Banaras Hindu university, Bhagwanpur, Varanasi, Uttar pradesh 221005. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Annamalaei |
Trauma centre and superspeciality hospital,Institute of medical sciences,Banaras hindu university |
Department of anaesthesiology and critical care,Institute of medical sciences, banaras hindu university, Varanasi, Uttar pradesh 221005.
Varanasi
UTTAR PRADESH |
7708731499
annamallaei@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Faculty of medicine,Institute of medical sciences,Banaras hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine spray |
Will receive Dexmedetomidine 1 microgram/kg diluted in normal saline to make 20ml solution and is sprayed over the surgical site towards the end of the surgery. |
| Intervention |
Ketamine spray |
Will receive Ketamine 1 mg/kg diluted in normal saline to make 20 ml solution and is sprayed over the surgical site towards the end of the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Lumbar spine patients posted for spine instrumentation surgery.
2. Age group between 18 and 60 years. |
|
| ExclusionCriteria |
| Details |
1. Refused to participate in the study.
2. A body mass index exceeding 30 kg/m2
3. Allergy to any studied medication
4. Hepatic or Renal insufficiency
5. Multiple level spine surgery or simultaneous/recent surgery
6. Antihypertensive medication with clonidine or other α2 agonists. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia (VAS) |
30mins,hours: 1,2,4,6,24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total rescue analgesic requirement in 24hr.
Any associated side effects like nausea /vomiting/sedation/shivering etc. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Nil].
- For how long will this data be available start date provided 28-08-2023 and end date provided 28-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The patients will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique into three equal groups: Group D: Will receive Dexmedetomidine 1 microgram/kg diluted in normal saline to make 20ml solution and is sprayed over the surgical site towards the end of the surgery. Group K: Will receive Ketamine 1 mg/kg diluted in normal saline to make 20 ml solution and is sprayed over the surgical site towards the end of the surgery. Group C: Will receive 20 ml of normal saline and is sprayed over the surgical site towards the end of the surgery. Under standard General anaesthesia, Lumbar spine surgery will be done, towards the end of surgery once the fixation will be done, Dexmedetomidine 1mcg/kg or Ketamine 1 mg/kg or normal salinewill be diluted in 0.9% Normal Saline to make 20 ml solution. This solution will be sprayed over the surgical site, thoracolumbar fascia, subcutaneous tissue using drug atomizer device which will atomize the drug and skin closure will be done. Patient will be turned supine and extubation will be done. VAS will be monitored at 30 mins after extubation, 1hr, 2h, 4h, 6h and 24h post extubation. Patients will be given rescue analgesia if VAS (≥4/10), with inj tramadol 2mg/kg asslow intravenous with prior medication with 0.1mg/kg Ondansetron. If pain still persist then Inj paracetamol 1 gm iv [max 4 gm in 24 h]will be given over 20min. Such demand in first 24 h will be monitored for the study. |