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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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