| CTRI Number |
CTRI/2024/11/076179 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing the Effects of Hyperbaric vs. Isobaric Ropivacaine for Abdominal Surgeries Using Thoracic Spinal Anesthesia |
|
Scientific Title of Study
|
Evaluation of intrathecal hyperbaric versus isobaric ropivacaine for abdominal surgeries under thoracic spinal anaesthesia a comparative 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 |
Dr Mamta Damor |
| Designation |
Associate Professor |
| Affiliation |
Medical college dungarpur |
| Address |
Depatment of anaesthesia
Medical college dungarpur
Dungarpur
RAJASTHAN
314001
India |
| Phone |
8441896796 |
| Fax |
|
| Email |
mamtadamor123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Goda |
| Designation |
Associate Professor |
| Affiliation |
Medical college dungarpur |
| Address |
Depatment of anaesthesia
Medical college dungarpur
Dungarpur
RAJASTHAN
314001
India |
| Phone |
8114425535 |
| Fax |
|
| Email |
vineeta7goda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Damor |
| Designation |
Associate Professor |
| Affiliation |
Medical college dungarpur |
| Address |
Depatment of anaesthesia
Medical college dungarpur
RAJASTHAN
314001
India |
| Phone |
8441896796 |
| Fax |
|
| Email |
mamtadamor123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Medical College Dungarpur, Rajasthan, India
pin code 314001 |
|
|
Primary Sponsor
|
| Name |
Medical College dungarpur |
| Address |
Department of Anesthesia,
medical college Dungarpur, Rajasthan,India.pin code-314001 |
| 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 Vineeta Goda |
Haridev Joshi Hospital |
general surgery operation theater, Haridev joshi Hospital, Govt. medical college Dungarpur
Dungarpur
RAJASTHAN |
8114425535
vineeta7goda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional 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 |
Thoracic spinal anaesthesia |
Thoracic spinal anaesthesia with hyperbaric Ropivacaine(0.75%) with Fentanyl |
| Comparator Agent |
Thoracic spinal anaesthesia |
Thoracic spinal anaesthesia with Isobaric ropivacaine(0.75%) with fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 65 years
2.American Society of Anesthesiologists physical status I-II
3.Scheduled for elective abdominal surgeries
4.Height: ≥140cm
5.Weight: 40kg - 70kg
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Patient with
a.Coagulopathies or on anticoagulant medication
b.Any specific disease includes severe cardiopulmonary disease, blood volume deficit, diabetic or other peripheral neuropathies, neurological deficit and severe hepatic renal disease
c.Psychiatric disorder
3.History of allergic reaction to study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory block and peak sensory level |
time till peak sensory level achieved upto 10 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of motor & sensory
2.Hemodynamic changes
3.Adverse effects / complications
|
Duration of motor & sensory block up to 6 hours post opratively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The aim of this study to evaluate and compare the safety of intrathecal hyperbaric versus isobaric ropivacaine in thoracic spinal anaesthesia underwent abdominal surgeries |