| CTRI Number |
CTRI/2025/01/079724 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the efficacy of dexmedetomidine and clonidine in spinal anesthesia in infra umbilical surgeries |
|
Scientific Title of Study
|
Effect of dexmedetomidine versus clonidine as an adjuvant to hyperbaric bupivacaine in subarachnoid block for the duration of analgesia in the patients
undergoing infra umbilical surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Shirabur |
| Designation |
Post graduate |
| Affiliation |
ESIC medical College and PGIMSR |
| Address |
Room 1 Department of anaesthesiology,2nd floor
Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
8197901367 |
| Fax |
|
| Email |
preetishirabur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Dhummansure |
| Designation |
Professor and HOD |
| Affiliation |
ESIC medical College and PGIMSR |
| Address |
2nd floor OT complex department of Anesthesiology ESIC medical College and PGIMSR Rajajinagar
Bangalore
KARNATAKA
560010
India |
| Phone |
9980050864 |
| Fax |
|
| Email |
10drdeepak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Shirabur |
| Designation |
Post graduate |
| Affiliation |
ESIC medical College and PGIMSR |
| Address |
Room 1 Department of anaesthesiology,2nd floor
Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
8197901367 |
| Fax |
|
| Email |
preetishirabur@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and PGIMSR Rajajinagar Bangalore 560010
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Preeti Shirabur |
| Address |
ESIC Medical college and PGIMSR,Rajajinagar,Bangalore-560010
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ESIC Medical college and PGIMSR |
ESIC medical college and
PGIMSR,Rajajinagar,Bangalore,560010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preeti Shirabur |
ESIC medical College and PGIMSR |
Department of Anesthesiology 2nd floor, room no 1,rajajinagar, banglore 560010
Bangalore
KARNATAKA |
8197901367
preetishirabur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
Comparing the duration of analgesia between clonidine and dexmedetomidine |
Comparing the efficacy of dexmedetomidine and clonidine in terms of duration of analgesia |
| Intervention |
Subarachnoid block with study drugs dexmedetomidine and clonidine |
Subarachnoid block given with the dexmedetomidine and clonidine and Comparing duration of analgesia between them |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to give informed consent
2. American Society of Anesthesiologists (ASA) physical status I or II
3. Age 18-60 years.
4. Elective infra umbilical surgical procedures requiring regional anesthesia. |
|
| ExclusionCriteria |
| Details |
1. BMI below 18 or above 35 kg/m2
2. Presence with known contraindications for spinal anesthesia.
3. Preoperative intake of opioid or non-steroidal anti- inflammatory drugs for chronic pain.
4. Chronic hepatic or renal failure. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
duration of analgesia between dexmedetomidine and clonidine as an adjuvant
to hyperbaric bupivacaine in spinal anesthesia for infra umbilical surgeries. |
6 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the onset of sensory and motor block between dexmedetomidine and
clonidine.
2. To compare the duration of the motor block between dexmedetomidine and clonidine.
|
6 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
09/02/2025 |
| 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
|
Dexmedetomidine being more potent drug compared to clonidine hence duration of analgesia will be longer in dexmedetomidine |