| CTRI Number |
CTRI/2024/05/067691 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| 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
|
Comparing two types methods of giving dexmedetomidine drug for seeing effects on increased pain control and muscle relaxation |
|
Scientific Title of Study
|
COMPARISON OF THE EFFECT OF INTRAVENOUS DEXMEDETOMIDINE ADMINISTERED AS BOLUS OR BOLUS PLUS INFUSION ON SENSORY AND MOTOR BLOCKADE AFTER SPINAL ANAESTHESIA IN LOWER LIMB SURGERIES- A PROSPECTIVE CONTROL 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 |
Drsai sanjana |
| Designation |
Post graduate |
| Affiliation |
Sri ramachandra medical college and hospital and research Centre |
| Address |
Room no 410, hostel V,Sri Ramachandra institute of higher education and research centre, porur
Chennai
TAMIL NADU
600116
India |
| Phone |
8760077147 |
| Fax |
|
| Email |
saisanju509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAYARAMAN |
| Designation |
Professor |
| Affiliation |
Sri ramachandra medical college and hospital and research Centre |
| Address |
A6 Department of Anaesthesiology, Sri Ramachandra institute of higher education and research centre, porur, chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841219820 |
| Fax |
|
| Email |
vjram2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Drsai sanjana |
| Designation |
Post graduate |
| Affiliation |
Sri ramachandra medical college and hospital and research Centre |
| Address |
Room no 410, hostel V,Sri Ramachandra institute of higher education and research centre, porur,chennai
Chennai
TAMIL NADU
600088
India |
| Phone |
8760077147 |
| Fax |
|
| Email |
saisanju509@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research centre, porur,chennai 600116,tamilnadu,india. |
|
|
Primary Sponsor
|
| Name |
Drsai sanjana |
| Address |
A6 department of Anaesthesiology, Sri Ramachandra institute of higher education and research centre, porur, chennai 600116 |
| Type of Sponsor |
Private 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 |
| Drsai sanjana |
Sri Ramachandra hospital and research Centre. |
A6,department of Anaesthesiology, Sri Ramachandra institute of higher education and research centre, porur, chennai 600118
Chennai
TAMIL NADU |
08760077147
saisanju509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institutional research ethics committee |
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 bolus vs bolus plus infusion |
Dexmedetomidine calculated according to body weight and group alloted into. In bolus group 1 mcg/kg for 10 minutes in beginning of surgery, in bolus plus infusion group 0.5 mcg/kg followed by 0.5 mcg / kg infusion for 1 hr of intra operative period |
| Comparator Agent |
Normal saline |
Bolus and infusion of normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Lower limb orthopedic surgery done under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Asa 3
Cardiac disease
Bradycardia
Hemodynamic unstable
Allergy to dexmedetomidine or local anesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check for Improved and prolonged sensory and motor blockade |
Intraoperative and end of surgery and 2 hours iin PACU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of intraoperative & postoperative shivering |
30 mins postspinal,end of surgery & 1hour after surgery |
|
|
Target Sample Size
|
Total Sample Size="222"
Sample Size from India="222"
Final Enrollment numbers achieved (Total)= "222"
Final Enrollment numbers achieved (India)="222" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
01/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To investigate the influence of administering a calculated dose of 1 µg/kg of dexmedetomidine intravenously either as a bolus (1 µg/kg) or as a bolus-plus-infusion (0.5 µg/kg each) on the sensorimotor effects following subarachnoid anesthesia given in L3- L4 space with 12.5 mg of hyperbaric bupivacaine for lower limb surgeries.
|