| CTRI Number |
CTRI/2022/08/044717 [Registered on: 17/08/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| 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 drugs for quality of block in spinal anaesthesia |
|
Scientific Title of Study
|
Additives dexmedetomidine vs fentanyl on the quality of intrathecal block with 0.5% hyperbaric bupivacaine in patients undergoing total knee arthroplasty : a double blind Randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini S |
| Designation |
Consultant Anaesthesia and Critical care |
| Affiliation |
Department of anaesthesia and critical care, first floor, IVY hospital Mohali |
| Address |
Department of anaesthesia and critical care, first floor, IVY health and life sciences pvt ltd (IVY hospital) sector 71 Mohali Punjab
Rupnagar
PUNJAB
160071
India |
| Phone |
7340941441 |
| Fax |
|
| Email |
dr.shalu83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini S |
| Designation |
Consultant Anaesthesia and Critical care |
| Affiliation |
Department of anaesthesia and critical care, first floor, IVY hospital Mohali |
| Address |
IVY health and life sciences pvt ltd (IVY hospital) sector 71 Mohali Punjab
Rupnagar
PUNJAB
160071
India |
| Phone |
7340941441 |
| Fax |
|
| Email |
dr.shalu83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanya Jindal |
| Designation |
1st year student of DNB anaesthesiology |
| Affiliation |
Department of anaesthesia and critical care, first floor, IVY hospital Mohali |
| Address |
IVY health and life sciences pvt ltd (IVY hospital) sector 71 Mohali Punjab
Rupnagar
PUNJAB
160071
India |
| Phone |
9818823127 |
| Fax |
|
| Email |
tanyajindal.103@gmail.com |
|
|
Source of Monetary or Material Support
|
| IVY health and life sciences pvt ltd (IVY hospital), sector 71, Mohali, punjab |
|
|
Primary Sponsor
|
| Name |
IVY hospital mohali |
| Address |
IVY health and life sciences pvt ltd (IVY hospital), sector 71, mohali, punjab |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Shalini S |
IVY hospital, mohali |
OT suite, first floor, department of anaesthesia and critical care, IVY health and life sciences pvt ltd (IVY Hospital), sector 71, Mohali, Punjab
Rupnagar
PUNJAB |
7340941441
dr.shalu83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee IVY hospital Mohali |
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
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and 0.5% hyperbaric bupivacaine |
16mg of 0.5% hyperbaric bupivacaine + 5microgram of dexmedetomidine. Intrathecal route, single administration |
| Intervention |
Fentanyl and 0.5% hyperbaric bupivacaine |
16mg of 0.5% hyperbaric bupivacaine + 25microgram fentanyl. Intrathecal route, single administration |
| Comparator Agent |
Normal saline and 0.5% hyperbaric bupivacaine |
16mg of 0.5% hyperbaric bupivacaine + 0.5ml of normal saline. Intrathecal route, single administration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II posted for total knee arthroplasty under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. ASA grade III and IV with severe systemic illness
2. Pregnancy
3. Patient with history of heart conduction abnormalities
4. Patient on alpha blockers
5. Any known hypersensitivity to the study drugs
6. Any contraindications to SA such as local infection, coagulopathy.
7. Patient with neurologic disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration and quality of sensory-motor block in spinal anaesthesia and duration of postoperative analgesia |
duration of motor anaesthesia (time taken to reach Bromage 0 from Bromage III after administration of subarachnoid block) and time of first rescue analgesia (the first time patient complains of pain at surgical site after administration of subarachnoid block) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect on hemodynamics plus
any intraoperative and/or postoperative complications
|
throughout the intraoperative period, at baseline, 0 min, 2, 4, 6, 8, 10, 15, 20, 25, 30, 45, 60, 90, 120, 150, 180 mins after administration of subarachnoid block |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2022 |
| Date of Study Completion (India) |
31/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison between dexmedetomidine and fentanyl, used as additive to 0.5% hyperbaric bupivacaine in spinal anaesthesia, for quality and duration of sensory-motor block and for duration of postoperative analgesia in patients undergoing total knee arthroplasty. Control group is the one in which normal saline is used as additive to 0.5% hyperbaric bupivacaine in spinal anaesthesia. |