| CTRI Number |
CTRI/2025/06/089344 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparison Between Clonidine And Dexmedetomidine As Spinal Additive In Prolongation Of Postoperative Analgesia. |
|
Scientific Title of Study
|
Intrathecal 0.75% Isobaric Ropivacaine versus 0.5% Hyperbaric Bupivacaine in transurethral resection of Prostate 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 |
Nantheta Ramu |
| Designation |
PG student |
| Affiliation |
SUDHA INSTITUTE OF MEDICAL SCIENCES |
| Address |
department of Anaesthesiology, sudha institute of medical sciences, perundurai road,erode,tamil nadu.
Erode
TAMIL NADU
638011
India |
| Phone |
9003884668 |
| Fax |
|
| Email |
nantheta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nithiyanandhan Palanisamy |
| Designation |
consultant |
| Affiliation |
SUDHA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology,sudha institute of medical sciences,perundurai road,erode,tamil nadu.
Erode
TAMIL NADU
638011
India |
| Phone |
7397625589 |
| Fax |
|
| Email |
ronnienithi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nantheta Ramu |
| Designation |
PG student |
| Affiliation |
SUDHA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology, sudha institute of medical sciences,perundurai road,erode,tamil nadu.
Erode
TAMIL NADU
638011
India |
| Phone |
9003884668 |
| Fax |
|
| Email |
nantheta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sudha Institute of Medical Sciences, perundurai road, erode district 638011, tamilnadu. |
|
|
Primary Sponsor
|
| Name |
Sudha Institute of Medical Sciences |
| Address |
181,sudha hospitals,perunduarai road,erode,tamil nadu.638011. |
| 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 |
| DrNantheta Ramu |
sudha hospitals |
Department of Anaesthesiology,sudha hospitals,perundurai road,erode,tamil nadu. 638011.
Erode
TAMIL NADU |
9003884668
nantheta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICS COMMITTEE, SUDHA HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% hyperbaric bupivacaine |
Patients will be receiving 2.8ml of 0.5% hyperbaric Bupivacaine (14mg). After skin infiltration with 2% lidocaine, lumbar puncture will be done using 26 G Quincke’s spinal needle at L3- L4
interspace in the midline.The prepared solution will be injected into subarachnoid space after confirming free flow of CSF and the patient will be made supine immediately after injection. |
| Intervention |
0.75% isobaric ropivacaine |
Patients will be receiving 2.8ml of 0.75% Isobaric
Ropivacaine (21mg). Total volume of the injected solution will be 2.8 ml. After skin infiltration with
2% lidocaine, lumbar puncture will be done using 26 G Quincke’s spinal needle at L3- L4 interspace in the midline.The prepared solution will be injected into subarachnoid space after
confirming free flow of CSF and the patient will be made supine immediately after injection. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 20-60yrs
2. ASA grade 1 & 2
3. Willing patients
|
|
| ExclusionCriteria |
| Details |
1. Uncooperative patients
2. Uncontrolled DM and SHTN
3. Allergy to study drugs
4. Height <150cms
5. Contraindication to spinal anaesthesia
6. Patient refusal
7. Infection at injection site
8. Increased intracranial pressure
9. Indeterminate neurological diseases
10. Coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Our primary objective is to evaluate the efficacy of two different drugs of same group (alpha2 adrenergic agonist) clonidine & dexmedetimidine in combination with 0.5% hyperbaric bupivacaine via intrathecal route with regard to the quality of anaesthesia namely time to attain highest sensory and motor blockade, haemodynamic changes and time to first rescue analgesia. |
WITHIN 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sedatory effects of both drugs in the postoperative period. |
5months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
unless contraindicated, almost all the lower abdomen and lower limb surgeries are done under spinal anaesthesia using hyperbaric bupivacaine. To prolong the sensory and motor blockade duration following spinal anaesthesia various additives has been used historically, here in our study i am going to compare alpha 2 agonist clonidine and dexmedetomidine as a spinal additive in prolonging the duration of spinal analgesia, hemodynamic fluctuations and its effects on sedation. |