| CTRI Number |
CTRI/2024/07/071589 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dexmedetomedine and fentanyl in spinal anaesthesia in lower limb surgeries. |
|
Scientific Title of Study
|
To compare and evaluate the effect of dexmedetomedine and fentanyl as adjuvant to intrathecal ropivacaine 0.5 percent heavy in lower limb surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akansha Singhal |
| Designation |
Junior resident |
| Affiliation |
Acharya Vinobha Bhave Rural Hospital, JNMC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 442001 AVBRH, JNMC.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8057335449 |
| Fax |
|
| Email |
singhal.akansha17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Taksande |
| Designation |
Professor, Department of Anaesthesia, JNMC |
| Affiliation |
Acharya Vinobha Bhave Rural Hospital, JNMC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7722037738 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akansha Singhal |
| Designation |
Junior resident |
| Affiliation |
Acharya Vinobha Bhave Rural Hospital, JNMC |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8057335449 |
| Fax |
|
| Email |
singhal.akansha17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinobha Bhave Rural Hospital, JNMC, Sawangi (Meghe),Wardha, Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Acharya Vinobha Bhave Rural Hospital |
| Address |
Sawangi (Meghe), Wardha, Maharashtra, India 442001 |
| Type of Sponsor |
Private 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 Akansha Singhal |
Acharya Vinobha Bhave Rural Hospital |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA |
8057335449
singhal.akansha17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine |
10 microgram dexmedetomedine as adjuvant to 15 mg of Ropivacaine 0.5 % (heavy) intrathecally at the beginning of procedure while administering spinal anaesthesia. |
| Comparator Agent |
Fentanyl |
20 micrograms fentanyl as adjuvant to 15 mg of ropivacaine 0.5 % (heavy) intrathecally at the beginning of procedure while administering spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II
2. Patient undergoing elective lower limb surgeries, duration of surgery 120-180 minutes
3. Age between 18 to 50 years old
4. Patient giving informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of
elevated renal parameters, elevated hepatic parameters, heart diseases of ischemic nature, disease related to heart valves, systemic hypertension, history of cancer, sepsis,
clotting disturbances and disorders
2. Consumption of narcotics or non steroidal anti inflammatory drugs a day prior to surgery
3. Drug allergy
4. Patients who don’t consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the onset and duration of sensory and motor blockade when Dexmeditomedine and fentanyl used as an adjuvant to ropivacaine 0.5% heavy in lower limb surgeries
|
06 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the duration of analgesia, hemodynamic stability, side effects
|
06 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/08/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The central nervous system
(CNS) comprises the brain and spinal cord. The term neuraxial anesthesia refers
to the placement of local anesthetic in or around the CNS. Spinal anesthesia is
a neuraxial anesthesia technique in which local anesthetic is placed directly
in the intrathecal space. This will be a randomized trial to test the effectiveness of Dexmedetomidine and fentanyl to intrathecal ropivacaine 0.5% heavy in lower limb surgeries. |