CTRI Number |
CTRI/2025/04/085839 [Registered on: 28/04/2025] Trial Registered Prospectively |
Last Modified On: |
11/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To compare efficacy and effectiveness of intrathecal dexmedetomidine versus intrathecal fentanyl as an additive to Isobaric Levobupivacaine in patients undergoing elective Lower Limb Orthopedic surgeries. |
Scientific Title of Study
|
A randomized study to compare the Efficacy and Safety of Intrathecal Dexmedetomidine versus Fentanyl as an adjuvant to Isobaric Levobupivacaine for Elective Lower Limb Orthopaedic 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 |
Dr Shriphal Meena |
Designation |
Senior Professor |
Affiliation |
Sawai Man Singh Medical College |
Address |
Department of Anaesthesiology Dhanwantri OPD Block SMS Medical College Jaipur
Jaipur RAJASTHAN 302004 India |
Phone |
9928350391 |
Fax |
|
Email |
dr.shriphal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shriphal Meena |
Designation |
Senior Professor |
Affiliation |
Sawai Man Singh Medical College |
Address |
Department of Anaesthesiology Dhanwantri OPD Block SMS Medical College Jaipur
Jaipur RAJASTHAN 302004 India |
Phone |
9928350391 |
Fax |
|
Email |
dr.shriphal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sunil Darwal |
Designation |
PG Resident |
Affiliation |
Sawai Man Singh Medical College |
Address |
Department of Anaesthesiology Dhanwantri OPD Block SMS Medical College Jaipur
Jaipur RAJASTHAN 302004 India |
Phone |
9717547804 |
Fax |
|
Email |
sunildarwal@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 India |
|
Primary Sponsor
|
Name |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur |
Address |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 India |
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 Shriphal Meena |
Sawai Man Singh Medical College and Attached Hospital Jaipur |
Department of Anaesthesia Sawai Man Singh Medical College and Attached Hospital Jaipur Rajasthan 302004 Jaipur RAJASTHAN |
9928350391
dr.shriphal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Office of Ethics Committee SMS Medical College and Attached Hospitals Jaipur |
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
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
Intrathecal Dexmedetomidine versus Fentanyl |
To compare the Efficacy and Safety of Intrathecal 5 mcg(0.5 ml) preservative free Dexmedetomidine versus Intrathecal 25mcg(0.5ml) preservative free Fentanyl as an adjuvant to 3ml 0.3% Isobaric Levobupivacaine on onset and duration of sensory and motor blockade in Elective Lower Limb Orthopaedic Surgery. Duration of intervention-Single Shot Injection. Route of administration-Intrathecal. |
Intervention |
Spinal Anaesthesia in Lower limb surgeries |
To compare the Efficacy and Safety of Intrathecal 5 mcg(0.5 ml) preservative free Dexmedetomidine versus Intrathecal 25mcg(0.5ml) preservative free Fentanyl as an adjuvant to 3ml 0.3% Isobaric Levobupivacaine on onset and duration of sensory and motor blockade in Elective Lower Limb Orthopaedic Surgery. Duration of intervention-Single Shot Injection. Route of administration-Intrathecal. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients who will give informed written consent.
2.Patients belonging to ASA Class I and II.
3.Patients 18–60 years of age of either sex.
4.Patients Height 150-180 cm.
5.Patients Weight 50-80 kg. |
|
ExclusionCriteria |
Details |
1.Patients having allergy to study drugs.
2.Patient should not be a part of other study.
3.Non co-operative patients.
4.Patients having absolute contraindications to spinal anaesthesia
5.Patients with Heart disease, Uncontrolled Diabetes mellitus, Morbid obesity, Coagulation Abnormalities and Vertebral deformities
6.Patients using alpha 2-adrenergic receptors antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitor. |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.Onset of sensory block
2.Onset of motor block
3.Duration of sensory blocks
4.Duration of motor block
5.To achieve Maximum sensory block |
1. 0 min
2. 01 min
3. 02 min
4. 03 min
5. 05 min
6. 10 min
7. 15 min
8. 30 min
9. 45 min
10. 60 min
11. 75 min
12. 90 min |
|
Secondary Outcome
|
Outcome |
TimePoints |
Hemodynamic changes ( SBP, DBP, MAP, HR, SPO2, RR) and adverse effects associated with drugs under study |
1. 0 min
2. 01 min
3. 02 min
4. 03 min
5. 05 min
6. 10 min
7. 15 min
8. 30 min
9. 45 min
10. 60 min
11. 75 min
12. 90 min |
|
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 4 |
Date of First Enrollment (India)
|
12/05/2025 |
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="2" 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
|
Spinal anaesthesia is the most commonly used technique for lower limb orthopaedic surgeries as it is very economical and easy to administer. This is due to the factors like avoiding the risks of general anesthesia such as pulmonary aspiration, bronchospasm, laryngospasm, cardiovascular response to intubation or risk of failed intubation and also allowing a patient to remain awake and enjoy the Painless experience of surgery. It also provides effective pain relief during intra operative and early postoperative period. Spinal anaesthesia also has rapid onset and low failure rate.
Spinal anesthesia is performed by placing a needle between the lumbar vertebrae and through the dura to inject anesthetic medication. Levobupivacaine, a new local anaesthetic, has been recently introduced into clinical practice because of its lower toxic effects for heart and central nervous system. Administrating the combinations of other classes of analgesics with local anesthetics has used to increase the duration and reduce side effects of analgesia. Some drugs have been used as adjuvants in spinal anesthesia to prolong intraoperative and postoperative analgesia including opioids (morphine, fentanyl and sufentanyl to hydromorphone, buprenorphine and tramadol), alpha2 agonists, neostigmine, vasoconstrictors, etc. Clonidine and dexmedetomidine are two alpha2 agonists affecting via pre- and post-synaptic alpha2 receptors.
For this a total of 60 patients (n = 60) undergoing lower limb orthopaedic surgeries will be randomly divided into two groups ( Group A and Group B). Group A patients will receive Isobaric Levobupivacaine 0.5% (3ml) with preservative free Dexmedetomidine 5mcg and Group B patients will receive Isobaric Levobupivacaine 0.5% (3ml) with preservative free Fentanyl 25mcg to subarachnoid block.
Patient will be received in operation theatre, intravenous cannula will be secured and hemodynamic variables will be noted. Surgery will be started after T10 level sensory blockade will achieve. Quantitative values of time of onset and duration of sensory and motor blockade, time taken to achieve maximum sensory blockade will be recorded. |