| CTRI Number |
CTRI/2026/02/103309 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of how dexmedetomidine and ketamine affect pain relief after lower limb fracture surgeries done under a spinal block |
|
Scientific Title of Study
|
Comparison of the effect of intravenous dexmedetomidine and ketamine on postoperative analgesia in lower limb fracture surgeries under subarachnoid block |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEGHNA R NAMBIAR |
| Designation |
Junior Resident |
| Affiliation |
Government medical college, Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college, Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
9567882706 |
| Fax |
|
| Email |
meghnarn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shafna K T |
| Designation |
Assistant professor |
| Affiliation |
Government medical college, Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college, Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
8506911421 |
| Fax |
|
| Email |
shafnakt87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shafna K T |
| Designation |
Assistant professor |
| Affiliation |
Government medical college, Kozhikode |
| Address |
Department of Anaesthesiology
Government medical college, Kozhikode, Kerala
Kozhikode
KERALA
673008
India |
| Phone |
8506911421 |
| Fax |
|
| Email |
shafnakt87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Kozhikode, Kerala, India PIN 673008 |
|
|
Primary Sponsor
|
| Name |
Government medical college Kozhikode |
| Address |
Government medical college, Kozhikode, Kerala, India, PIN 673008 |
| 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 Meghna R Nambiar |
Government Medical College, Kozhikode |
Department of Anesthesiology, Major operation theatre complex, Government medical college, Kozhikode
Kozhikode
KERALA |
9567882706
meghnarn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for lower limb fracture surgeries 2.ASA PS I and II |
|
| ExclusionCriteria |
| Details |
1.Patients allergic to dexmedetomidine or ketamine 2.Patients with ischemic heart disease, severe renal and liver impairment
3.Patients on beta blockers
4.Duration of surgery more than 120 minutes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare postoperative analgesia in terms of duration of analgesia, total rescue
analgesia and NRS pain scores |
Postoperative analgesia will be evaluated by Numerical rating scale at 0,1,2,4,6,12 & 24 hours from stopping infusion of study drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative & postoperative sedation scores
|
Intraoperatively every 30 minutes from administration of bolus dose of study drug.
postoperatively at 0,1,2,4,6,12 & 24 hours from stopping infusion of study drug. |
| To assess side effects like hemodynamic instability |
Hemodynamics will be monitored every 5 minutes intraoperatively. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Following approval from the Institutional Research and Ethics Committee, the study will be
conducted at our institution involving patients scheduled for lower limb fracture surgeries
under subarachnoid block. A comprehensive pre-anaesthetic evaluation will be performed,
and the study protocol will be thoroughly explained to each patient. Individuals who meet the
inclusion criteria and provide informed consent will be enrolled in the study. |