| CTRI Number |
CTRI/2024/06/068438 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An analysis of comparing the effect of intravenous dexamethasone in spinal anesthesia in elective cesarean section. |
|
Scientific Title of Study
|
A comparative study on the effect of intravenous dexamethasone vs placebo in subarachnoid block with 0.5 percent hyperbaric bupivacaine for elective cesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isita Jana |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College And Hospital |
| Address |
Department of Anesthesiology,
Gauhati Medical College And Hospital,
Bhangagarh,
Kamrup Metro,
Guwahati,
Pin- 781032
Kamrup
ASSAM
781032
India |
| Phone |
8961764592 |
| Fax |
|
| Email |
isitajana500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aldiona Shanpru Bhattacharya |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology,
Gauhati Medical College and Hospital,
Bhangagarh,
Guwahati,
Pin- 781032
Kamrup
ASSAM
781032
India |
| Phone |
9435014739 |
| Fax |
|
| Email |
aldiona.shanpru1958@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Isita Jana |
| Designation |
Postgraduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology,
Gauhati Medical College and Hospital,
Kamrup Metro,
Guwahati
Pin- 781032
Kamrup
ASSAM
781032
India |
| Phone |
8961764592 |
| Fax |
|
| Email |
isitajana500@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Gauhati Medical College and Hospital |
| Address |
Department of Anesthesiology,
Gauhati Medical College and Hospital,
Guwahati,
Assam,
pin-781032 |
| 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 Isita Jana |
Gauhati Medical College and Hospital |
Department of Anesthesiology,
Gauhati Medical College and Hospital,
Guwahati,
Pin-781032
Kamrup
ASSAM |
8961764592
isitajana500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF GAUHATI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexamethasone |
In one group intra venous Dexamethasone 8mg given just after giving spinal anesthesia. |
| Comparator Agent |
Normal saline |
In another group intravenous normal saline given after giving spinal anesthesia. Then we will compare between the duration of analgesia between two groups. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women between the age 18years to 35 years.
2.All the cases should be elective LSCS cases. |
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent.
2.Patients having coagulopathy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the duration of analgesia when intravenous dexamethasone is added in patients receiving spinal anesthesia with 0.5% hyperbaric bupivacaine.
|
2,4,6,12,24 POSTOPERATIVE HOURS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the duration of motor and sensory block when iv dexamethasone is added in spinal anesthesia in LSCS. |
2,4,6,12,24 POSTOPERATIVE HOURS
|
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/07/2024 |
| 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 Yet Recruiting |
| 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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [isitajana500@gmail.com].
- For how long will this data be available start date provided 01-06-2024 and end date provided 31-05-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
WE CAN EVALUATE THE DURATION OF ANALGESIA WHEN IV DEXAMETHASONE GIVEN WITH SPINAL ANESTHESIA.WE CAN ALSO EVALUATE THE DURATION OF SENSORY AND MOTOR BLOCK IF IV DEXAMETHASONE IS ADDED. |