| CTRI Number |
CTRI/2025/06/089076 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of A Drug Dexmedetomidine by Two Different Route Intravenous or Intrathecal With Ropivacaine Heavy in Spinal Block for Lower Limb Orthopaedic Surgery |
|
Scientific Title of Study
|
Intravenous Versus Intrathecal Dexmedetomidine As an Adjuvant to 0.75% Hyperbaric Ropivacaine in Spinal Anaesthesia for Lower Limb Orthopaedic Surgery -A Randomized
Double Blind Comparative study |
| 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 Sandeep Sharma |
| Designation |
Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia, R.N.T Medical College,
Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
09214323557 |
| Fax |
|
| Email |
sharma0979@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Sharma |
| Designation |
Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia, R.N.T Medical College,
Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
09214323557 |
| Fax |
|
| Email |
sharma0979@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Vyas |
| Designation |
PG Resident |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia, R.N.T Medical College,
Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN
313001
India |
| Phone |
09468608278 |
| Fax |
|
| Email |
anuradhavyas03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia R.N.T Medical College, Udaipur 313001 Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of Anaesthesia, R.N.T Medical College, Udaipur
Rajasthan
313001
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 Anuradha Vyas |
Maharana Bhupal Government Hospital |
2nd Floor Main OT Orthopaedic Trauma Centre Building, Main Orthopaedic OT, R.N.T Medical College, Udaipur, Rajasthan
313001
India
Udaipur
RAJASTHAN |
9468608278
anuradhavyas03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R.N.T. MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS, UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S724||Fracture of lower end of femur, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S823||Fracture of lower end of tibia, (5) ICD-10 Condition: S723||Fracture of shaft of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal Hyperbaric Ropivacaine and Intravenous Dexmedetomidine |
Duration of analgesia is evaluate in Hyperbaric Ropivacaine 0.75 percentage (18.75mg) and Intravenous Dexmedetomidine 0.5 mcg per kg in 100ml NS over 15min |
| Comparator Agent |
Intrathecal Hyperbaric Ropivacaine with Dexmedetomidine |
Duration of analgesia is evaluate in Hyperbaric Ropivacaine 0.75 percentage (18.75mg) with 5 mcg Dexmedetomidine |
| Intervention |
Spinal Anaesthesia |
Duration of Analgesia is compared between Hyperbaric Ropivacaine 0.75 percentage(18.75mg)with intrathecal (5mcg) or intravenous (5mcg per kg) Dexmedetomidine in spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with ASA physical status Grade I and II
Patient undergoing elective surgery under spinal anaesthesia
Patient with Mallampati Class I and II |
|
| ExclusionCriteria |
| Details |
Pregnant patients.
Patients having coagulation abnormalities, platelet count less than 75000, INR more than 1.5, or on
anticoagulants.
Patients having systemic illness (severe hypovolemia, raised intracranial pressure,
neuromuscular diseases, ischemic, valvular,congenital heart diseases, psychiatric,
hematological disorder).
Patients having any absolute contraindications for spinal anesthesia.
Patient refusal to participate in study.
Any allergy to study drugs or local anaesthetic drugs.
Short stature (height less then 150cms)
Patients with spinal deformity.
Patients with BMI more than 30. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate and Compare the Duration of Analgesia.
|
0 min,15min,30min,60min,2 hour,3 hour,4 hour,5 hour,6 hour,7 hour,8 hour,12 hour,16 hour,20 hour,24 hour
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensory block
Onset and duration of motor block
Peak sensory level achieved
Time to reach peak sensory level
Maximum Bromage score achieved
Consumption of rescue analgesic drug in 24 hours post operatively
Sedation Score
Haemodynamic parameters
Adverse effects, if any |
0 min,15min,30min,60min,2 hour,3 hour,4 hour,5 hour,6 hour,7 hour,8 hour,12 hour,16 hour,20 hour,24 hour
|
|
|
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)
|
30/06/2025 |
| 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="0"
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
|
The aim of the study will be to evaluate and compare the effect of intravenous versus intrathecal dexmedetomidine as an adjuvant to hyperbaric 0.75% ropivacaine in spinal anaesthesia for lower limb orthopaedic surgery with Primary objective - to evaluate and compare the duration of analgesia Secondary objectives- to evaluate and compare onset and duration of sensory and motor block, peak sensory level achieved, time to reach peak sensory level, maximum bromage score achieved, consumption of rescue analgesic drug in 24 hours post operatively, sedation score, haemodynamic parameters, adverse effects,if any.
This study will be conducted in patient who will fulfill the inclusion criteria will be enrolled in the study. They will be randomly into two equal groups of 30 patients in each group.
Group IV - Subarachnoid block with 0.75% of hyperbaric ropivacaine 2.5ml (18.75 mg) + normal saline 0.1ml and IV infusion of 0.5mcg per kg dexmedetomidine in 100ml NS over 15 min Group IT - Subarachnoid block with 0.75% of hyperbaric ropivacaine 2.5ml (18.75 mg) + 5mcg dexmedetomidine and IV infusion of 100ml NS over 15 min
|