| CTRI Number |
CTRI/2020/03/023964 [Registered on: 13/03/2020] Trial Registered Prospectively |
| Last Modified On: |
11/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF THREE DOSES OF DEXMEDETOMIDINE AS AN ADJUVANT TO BUPIVACAINE ON DIFFERENTIAL ANALGESIA IN SURGERIES UNDER SUBARACHNOID BLOCK |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF THREE DOSES OF DEXMEDETOMIDINE AS AN ADJUVANT TO BUPIVACAINE ON DIFFERENTIAL ANALGESIA IN ADULT PATIENTS UNDERGOING ELECTIVE INFRAUMBLICAL SURGERIES UNDER SUBARACHNOID BLOCK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dwara Lohitha |
| Designation |
PG RESIDENT |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir
Medical College and Safdarjang Hospital, Ansari Nagar,New delhi
South West
DELHI
110029
India |
| Phone |
9398703693 |
| Fax |
|
| Email |
dwaralohitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anoop R Gogia |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir
Medical College and Safdarjang Hospital, Ansari Nagar,New delhi
South West
DELHI
110029
India |
| Phone |
9810318291 |
| Fax |
|
| Email |
gogiaanoop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anoop R Gogia |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir
Medical College and Safdarjang Hospital, Ansari Nagar,New delhi
South West
DELHI
110029
India |
| Phone |
9810318291 |
| Fax |
|
| Email |
gogiaanoop@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjang Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjang Hospital, Ansari
Nagar , New Delhi |
| 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 |
| DWARA LOHITHA |
Vardhman Mahavir Medical College and Safdarjang Hospital |
Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjang Hospital, Ansari
Nagar , New Delhi
South West
DELHI |
9398703693
dwaralohitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjang Hospital Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of three doses of Dexmedetomidine as an adjuvant to Bupivacaine
on Differential analgesia in adult patients undergoing elective infraumblical surgeries under Subarachnoid block |
Group BD 2.5 will recieve intrathecal Bupivacaine (H) 0.5% + Dexmedetomidine 2.5μg
Group BD 5 will recieve intrathecal Bupivacaine (H) 0.5% + Dexmedetomidine 5μg
Group BD 10 will recieve intrathecal Bupivacaine (H) 0.5% + Dexmedetomidine 10μg and the results will be compared |
| Comparator Agent |
Duration of differential Analgesia |
Duration of Differential Analgesia in the groups recieving three different doses of Dexmeditomidine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of age 18-65y, of either gender, belonging to American Society of
Anaesthesiologists (ASA) physical status I and II, scheduled for elective Infra-umbilical
surgeries under subarachnoid block. |
|
| ExclusionCriteria |
| Details |
Patients with contraindication of Subarachnoid block.
Patients having hyper-sensitivity to drugs used in the study.
Patients with significant co-morbid conditions.
Patients with history of analgesic abuse/drug abuse/ cognitive impairment/ psychiatric illness. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study and compare duration of differential analgesia in patients undergoing elective Infra
Umbilical surgeries using three different doses of Intrathecal Dexmedetomidine (2.5μg, 5μg,
10μg) as an adjuvant to Bupivacaine(H) 0.5% in subarachnoid block. |
Time from onset of Bromage score 0 to requirement of first rescue analgesic. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare total duration of analgesia, onset of sensory and motor blockade, intraoperative hemodynamic parameters and sedation, cumulative analgesic use in 24-hour period postoperatively. |
Intraoperative and Post operative till 24 hours |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
16/03/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an interventional comparative study to find out and compare duration of differential analgesia, using three doses of intrathecal Dexmedetomidine as an adjuvant to Bupivacaine(H) 0.5% in adult patients undergoing elective infra umblical surgeries in subarachnoid block. |