| CTRI Number |
CTRI/2024/01/061973 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison between one sedative and one opioid as additive to a local anaesthetic drug while giving spinal anaesthesia for surgeries involving female reproductive tract |
|
Scientific Title of Study
|
Comparison between dexmedetomidine and fentanyl as adjuvant to intrathecal levobupivacaine on spinal block characteristics in gynaecological 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 V A Sabapathy |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rasika Priya M |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636007
India |
| Phone |
8129340367 |
| Fax |
|
| Email |
rasikamadhan1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Ganesan |
| Designation |
Post Graduate Resident Anaesthesiology |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
| Address |
Room number 15 Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
6282556025 |
| Fax |
|
| Email |
dr.arjunganesan@outlook.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital |
| Address |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital 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 Arjun Ganesan |
Vinayaka Missions Kirupananda Variyar Medical College and Hospital Chinnaseeragapadi Salem |
Room Number 15 Department of Anaesthesiology
Salem
TAMIL NADU |
6282556025
dr.arjunganesan@outlook.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 Hospital |
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 drug |
Comparison between dexmedetomodine and fentanyl as adjuvant to intrathecal levobupivacaine on spinal block characteristics in gynaecological surgeries |
| Comparator Agent |
Dexmedetomidine |
Mixture of 0.5% hyperbaric levobupivacaine 3 millilitre with dexmedetomidine 5 micrograms intrathecally single shot stat dose |
| Comparator Agent |
Fentanyl |
Mixture of 0.5% hyperbaric levobupivacaine 3 millilitre with fentanyl 25 micrograms intrathecally single shot stat dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade I and 2.
2. Age between 18-60 years.
3. Gynaecological surgeries.
4. Patient giving valid informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Age more than 60 years and less than 18 years
2.ASA grade 3 & 4.
3.Patient refusal.
4.Patients with local infection at puncturing site.
5.Patients with Ischemic and Rheumatic heart diseases.
6.Patients with coagulation defects and patients on anticoagulants.
7.Patients allergic to local anesthetic drugs.
8. Surgeries converted to general anaesthesia. |
|
|
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="60"
Sample Size from India="60"
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)
|
01/02/2024 |
| 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 31-12-2023 and end date provided 15-12-2025?
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
|
Comparison Between Dexmedetomidine and Fentanyl as adjuvant to intrathecal Levobupivacaine on spinal block characteristics in gynaecological procedures. Comparing the duration of sensory blockade and motor blockade after administration of spinal anaesthesia and also post spinal anaesthesia, after how much time the first rescue analgesia was required by the patient. |