| CTRI Number |
CTRI/2019/02/017789 [Registered on: 22/02/2019] Trial Registered Prospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of dexmedetomidine with bupivacaine in turp |
|
Scientific Title of Study
|
Effect of intrathecal dexmedetomidine as an adjuvant to low‑ dose bupivacaine in patients undergoing transurethral resection of prostate - A prospective randomised - double blind 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 Aakriti Sharma |
| Designation |
Postgraduate student |
| Affiliation |
Jawahar lal nehru medical college, ajmer, rajasthan |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
7014321360 |
| Fax |
|
| Email |
aakritias2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor and guide |
| Affiliation |
Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior professor and guide |
| Affiliation |
Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology jawahar lal nehru medical Medical College ajmer |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology Jln Medical College ajmer |
| Address |
Department of anaesthesiology jln medical college ajmer |
| 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 Aakriti Sharma |
Jln Medical College ajmer |
Department of anaesthesiology jln medical college ajmer
Ajmer
RAJASTHAN |
07014321360
aakritias2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN medical college |
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 |
| Comparator Agent |
Bupivacaine alone and with Dexmedetomidine |
To compare duration of analgesia |
| Intervention |
Spinal anasthesia |
For Onset of motor and sensory block |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.Male patients between 50 to 70 years of age.
2.ASA physical status 1,2 and 3. |
|
| ExclusionCriteria |
| Details |
1. ASA physical status 4,5 & 6. 2. Patients refusal.3. Patients with peripheral sensorineural deficit. 4. Patients is sensitive or allergic to study medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Duration of study is around 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. ASA physical status 4,5 and 6. 2. Patients refusal. 3. Patients with peripheral sensorineural deficit. 4. Patients is sensitive or allergic to study medications. 5. Patients on anticoagulants. 6. Infection at the site of of lumbar puncture. 7. Patients who are taking α2 adrenergic agonist or antagonists. 8. Pre existing severe cardiac disease, heart block/dysrhythmias. 9. Contraindications to subarachnoid block. |
Duration of study is around one year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2019 |
| Date of Study Completion (India) |
06/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the effects of intrathecal dexmedetomidine as an adjuvant to low dose bupivacaine in patients undergoing transurethral resection of prostate with respect to: PRIMARY OBJECTIVE: 1. Duration of analgesia SECONDARY OBJECTIVES: 1. Block characteristics (onset and duration of sensory and motor block ). 2. First rescue analgesic requirement. 3. Total rescue analgesic requirement in 24 hour. 4. Haemodynamic changes. 5. Side effects, if any. |