| CTRI Number |
CTRI/2024/03/064710 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparing between two drugs one sedative and another pain relieving drug for giving anaesthesia in lower abdominal surgeries |
|
Scientific Title of Study
|
Comparing the effects of dexmedetomidine versus morphine as adjuvant to 0.5% levobupivacaine for spinal anaesthesia in 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 R Brindha |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9677446581 |
| Fax |
|
| Email |
mskbrins63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Naveena |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9486198407 |
| Fax |
|
| Email |
naveenasen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Nandhini |
| Designation |
PG Student |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
8056560871 |
| Fax |
|
| Email |
nandhu.roysterzz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Chinnaseeragapadi Salem |
| 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 |
| Dr L Nandhini |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU |
8056560871
nandhu.roysterzz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem |
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 |
Comparison between alpha 2 agonist drug and opioid |
Comparing between dexmedetomidine 5 micrograms and morphine 100 micrograms with 0.5% levobupivacaine 3 millilitre intrathecally in lower abdominal surgeries upto a period of administration of first rescue analgesic in post operative period |
| Comparator Agent |
Dexmedetomidine |
Mixture of 0.5% hyperbaric levobupivavaine 3 millilitre with dexmedetomidine 5 micrograms intrathecally single shot stat dose |
| Comparator Agent |
Morphine |
Mixture of 0.5% hyperbaric levobupivacaine 3 millilitre with morphine 100 micrograms intrathecally single shot stat dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and 2.
2. Age between 18 to 60 years.
3.Elective lower abdominal surgeries.
4. Patient giving valid informed
consent. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age less than 18 years and more than 60 years
3. ASA grade 3 and 4
4. Patients posted for emergency surgeries
5. Patient with local infection at puncturing site
6. Patients with ischaemic and rheumatic heart disease
7. Patients with coagulation defects and patients on anticoagulants
8. Patients allergic to local anesthetic drugs.
9. Patients with neuromuscular disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The time for first rescue analgesia after the
spinal anaesthesia will be prolonged. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total dose of rescue analgesia required in 24 h
post-operatively will be reduced. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - -
- For how long will this data be available start date provided 01-04-2024 and end date provided 01-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Comparing between dexmedetomidine 5 micrograms and morphine 100 micrograms as adjuvant to 0.5% levobupivacaine 3 millilitre for spinal anaesthesia in lower abdominal surgeries. Comparing the duration of sensory blockade and motor blockade after spinal anaesthesia while using either dexmedetomidine or morphine as adjuvant with levobupivacaine and also how much time prolonged for administering the first rescue analgesic in the post operative period. |