| CTRI Number |
CTRI/2024/05/066941 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the total duration of analgesia when dexamethasone and dexmedetomidine are added to bupivacaine in spinal anaesthesia. |
|
Scientific Title of Study
|
A prospective randomized comparative study to evaluate efficacy of intrathecal dexamethasone and dexmedetomidine added as adjuvant to bupivacaine in pregnant patient posted for elective LSCS. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samarpan Patel |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Seminar room, Department of anaesthesia, Jawaharlal Nehru Medical College.
Sawangi,Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000748295 |
| Fax |
|
| Email |
patel.samarpan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aruna chandak |
| Designation |
Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Seminar room, Department of anaesthesia, JNMC, Sawangi(Meghe), Wardha.
Surabhi, Esaji layout, Nagpur road, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422903551 |
| Fax |
|
| Email |
doctorchandak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samarpan Patel |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Seminar room, Department of anaesthesia, Near Hippocrates Hall, JNMC, Sawangi(Meghe), Wardha.
Raghobaji hostel,Room No-S1, Sawangi, Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000748295 |
| Fax |
|
| Email |
patel.samarpan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya vinoba Bhave Rural Hospital,sawangi,wardha. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
SAWANGI,WARDHA |
| 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 |
| SAMARPAN PATEL |
Acharya Vinoba Bhave Rural Hospital |
Seminar Room, Department of Anaesthesia, Sawangi, and Wardha.
Wardha
MAHARASHTRA |
7000748295
patel.samarpan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,DMIMS,Sawangi(Meghe),Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone Group |
Bupivacaine 10mg plus Dexamethasone 8mg via the intrathecal route.
To see the duration of postoperative analgesia until first rescue analgesia.
Route-Intrathecal
Total duration of intervention: from induction until first rescue analgesia. |
| Intervention |
Dexmedetomidine Group |
Bupivacaine 10 mg plus Dexmedetomidine 10mcg via intrathecal route.
To see the duration of postoperative analgesia until first resuce analgesia.
Route-Intrathecal.
Total duration of intervention: from induction until first rescue analgesia. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
RANDOMISED CONTROLL TRIAL |
Comparison of postoperative analgesia between bupivacaine (10 mg) with dexmedetomidine (10 mcg) and bupivacaine (10mg) with dexamethasone (8 mg) in spinal anaesthesia in elective caesarian section. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA Grades 1 & 2
BMI 20 TO 30
No history of bleeding tendency
No previous uterine operation except cesarian section
Living foetus
|
|
| ExclusionCriteria |
| Details |
ASA 3 & 4
Patient having systemic disease
Severe coronary insufficiency
BMI > 30
The patient requires repeat intrathecal bupivacaine. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The duration of postoperative analgesia is longer with dexamethasone as an adjuvant with bupivacaine. |
The time duration will be noted for the first rescue analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative hemodynamics
Prevention of perioperative shivering
comparative study of sedation
|
2 Years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
16/05/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
In our study, we are comparing the duration of postoperative analgesia between bupivacaine with dexmedetomidine and bupivacaine with dexamethasone in an elective caesarian section posted under spinal anaesthesia. Also, we are going to see intraoperative hemodynamics, sedation, and shivering. Our hypothesis says that bupivacaine with dexamethasone has better post operative analgesia than dexmedetetomidine. |