| CTRI Number |
CTRI/2022/10/046902 [Registered on: 31/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two different routes of administration of Dexmedetomidine for post operative pain relief in patients receiving spinal anesthesia for lower limb orthopedic surgeries. |
|
Scientific Title of Study
|
COMPARISON OF INTRATHECAL VERSUS INTRAVENOUS DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC BUPIVACAINE FOR SUBARACHNOID BLOCK IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anup Suresh |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Vydehi Institute Of Medical Sciences And Research Centre |
| Address |
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
9441249655 |
| Fax |
|
| Email |
anupsuresh28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvina |
| Designation |
Assistant Professor, Department of Anesthesiology |
| Affiliation |
Vydehi Institute Of Medical Sciences And Research Centre |
| Address |
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
6366279888 |
| Fax |
|
| Email |
suvi11492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANUP SURESH |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
Vydehi Institute Of Medical Sciences And Research Centre |
| Address |
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
9036850860 |
| Fax |
|
| Email |
anupsuresh28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Medical sciences and Research Center |
|
|
Primary Sponsor
|
| Name |
Vydehi Institute of Medical sciences and Research Center |
| Address |
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066 |
| 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 |
| DrAnup Suresh |
Vydehi Institute of Medical Sciences and Research Center |
82, Nallurahalli Main Rd, near BMTC 18th Depot, Vijayanagar, Nallurhalli, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA |
9036850860
anupsuresh28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Comparison of Intrathecal dose of 5 microgram of Dexmedetomidine versus Intravenous route dose of 0.5 microgram per kg of Dexmedetomidine given as an adjuvant for Spinal Anesthesia(sub arachnoid block) with Bupivacaine |
| Intervention |
Spinal Anesthesia |
Primary anaesthetic technique for all patients will be Sub- arachnoid block with 3ml volume of drug which includes 0.5% hyperbaric Bupivacaine ,as the common local anesthetic, with the comparator agent being given either intrathecally Or intravenously. The duration of sensory and motor blockade will be checked at 0,3,6,9,15,30,60 minutes and then at 2nd,4th,6th,8th,12th and 24th hour after spinal anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing lower Limb orthopaedic surgeries under Neuraxial blockade.
2) Patients belonging to Americans Society of Anaesthesiologists physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1) Patients who did not consent
2) Allergies to Dexmedetomidine and Bupivacaine
3) Patients who underwent prolonged surgery requiring epidural activation
4) Emergency surgeries
5) Conversion to general Anesthesia
6) Localised infection at needle site
7) BMI> 35 kg/m2
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare in both groups onset and duration of motor and sensory blockade |
at 0th minute , 3rd, 6th, 9th, 12th, 15th, 30th, 60th minute then at 2nd ,4th, 6th ,10th , 12th and 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesia
(Tramadol 50mg in 100ml normal saline) |
Time noted from the time of intervention. |
| Total rescue analgesic doses given in 24 hours |
Time at which rescue Analgesia given is noted. |
| Sedation scores |
Intra operative sedation scores until the surgery is complete is noted. |
| Incidence of shivering |
Intra operative from the time of intervention to completion of surgery. |
| Adverse effects (if any) |
From the time of intervention up to 24 hours post procedure. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be conducted in Vydehi Indtuitute of medical sciences and Research Center recruiting patients posted for lower limb orthopedic surgeries. All patients will be receiving spinal anesthesia with Dexmedetomidine either as an adjuvant to spinal as 5 mcg intrathecally Or as an IV supplement at 0.5microgram per kg in 100 ml normal saline 15 minutes before spinal anesthesia. The effect of this drug on the intervention will be measured in terms of onset and duration of motor and sensory blockade that the spinal anesthesia provides for these surgeries The study will be conducted on 90 patients over a period of a year. The results will he directed in the comparison of the two routes of administration of Dexmedetomidine as an adjuvant to spinal anesthesia in lower limb orthopedic surgeries. The study shall also have secondary objectives of noting shivering sedation and any adverse effects due to the intervention. |