| CTRI Number |
CTRI/2024/09/074349 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of the effects of Fentanyl and Dexmedetomidine in spinal anesthesia |
|
Scientific Title of Study
|
Comparison of the Effectiveness of Block Characteristics and Postoperative Analgesia of Fentanyl Versus Dexmedetomidine Versus Combination of Dexmedetomidine & Fentanyl as Adjuvants to Intrathecal Hyperbaric Bupivacaine in Lower Limb Orthopedic and Lower Abdominal Surgeries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Mandya Institute of Medical College Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Mandya Institute of Medical College Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Mandya Institute of Medical College Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical Sciences, Mandya, Karnataka 571401 |
|
|
Primary Sponsor
|
| Name |
Dr Shivakumar G |
| Address |
Professor and HOD
Department of Anaesthesiology
Mandya Institute of Medical Sciences,Mandya, Karnataka- 571401 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Archana B N |
Assistant Professor
Department of Anaesthesiology
Mandya Institute of Medical Sciences Mandya |
| Dr Shwetha A |
Postgraduate Student
Department of Anaesthesiology
Mandya Institute of Medical Sciences Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shwetha A |
Mandya Institute of Medical Sciences |
Major OT complex
Department of Anaesthesiology
Mandya
KARNATAKA |
9940839422
shwethaarun08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution 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
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with height 150-180cm and weight 40-80kg belonging to American Society of Anaesthesiologists grade I and II undergoing lower limb and lower abdominal surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
patients taking any kind of analgesics, alpha adrenergic receptor antagonist drugs, chronic opioid usage, having bleeding disorders and infection at the site of needle insertion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of the sensory and motor block and the duration of analgesia between the groups |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the intraoperative hemodynamic parameters between the groups |
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
We formulated this study to compare the onset and effectiveness of sensory and motor block characteristics and postoperative analgesia between Fentanyl versus Dexmedetomidine versus a combination of both as adjuvants to intrathecal bupivacaine in lower limb and lower abdominal surgeries in spinal anaesthesia. We chose this study to compare the study drug effectiveness as adjuvants in spinal anaesthesia. |