| CTRI Number |
CTRI/2021/09/036556 [Registered on: 16/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of characteristics of two drugs namely, CLONIDINE and FENTANYL as adjuncts to hyperbaric BUPIVACAINE, a drug commonly used for spinal anaesthesia in caesarean section |
|
Scientific Title of Study
|
Comparison of block characteristics of intrathecal CLONIDINE and FENTANYL as adjuncts to hyperbaric BUPIVACAINE in lower segment caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Mary Sebastian |
| Designation |
DNB TRAINEE |
| Affiliation |
Nazareth Hospital |
| Address |
Nazareth hospital , Laitumkrah
Shillong
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
8746963175 |
| Fax |
|
| Email |
pooja.mary93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himjyoti Das |
| Designation |
HOD department of Anaesthesia |
| Affiliation |
Nazareth Hospital |
| Address |
Nazareth hospital , Laitumkrah
Shillong
Laitumkrah
Shillong,Meghalaya
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
9862018017 |
| Fax |
|
| Email |
himjyotidas@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Mary Sebastian |
| Designation |
DNB TRAINEE |
| Affiliation |
Nazareth Hospital |
| Address |
Nazareth hospital , Laitumkrah
Shillong
East Khasi Hills
MEGHALAYA
793003
India |
| Phone |
8746963175 |
| Fax |
|
| Email |
pooja.mary93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nazareth hospital
Laitumkhrah, Shillong,Meghalaya |
|
|
Primary Sponsor
|
| Name |
nazareth hospital |
| Address |
laitumkhrah
shillong |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja |
Nazareth Hospital |
department of anaesthesia
East Khasi Hills
MEGHALAYA |
8746963175
pooja.mary93@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: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLONIDINE |
0.5mcg/kg of CLONIDINE added to 0.06mg/cm of intrathecal BUPIVACAINE for group 2 patients undergoing caesarean section |
| Comparator Agent |
FENTANYL |
0.5mcg/kg of FENTANYL added to 0.06mg/cm of height of intrathecal BUPIVACAINE for group 1 patients undergoing caesarean section |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with singleton pregnancy, belonging to ASA grade I and II
2. Patients posted for elective and emergency LSCS
|
|
| ExclusionCriteria |
| Details |
1.Patients with major neurological, cardiovascular, respiratory, renal, coagulation disorders
2.Patients with known hypersensitivity to local anaesthetics or study drugs.
3.Patients with local infection/spine deformity
4.Patients who refuse to give consent.
5.Patients whose height an weight cannot be measured before the surgery |
|
|
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 |
| To evaluate block characteristics of Intrathecal CLONIDINE versus FENTANYL as adjuncts to BUPIVACAINE in caesarean section |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the levels of sedation and associated side effects with the 2 test drugs |
1 year |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized comparative study designed with a primary objective to determine whether doses of 0.5mcg/kg FENTANYL and 0.5mcg/kg CLONIDINE are equally effective when given as adjuncts to hyperbaric BUPIVACAINE 0.06mg/cm of height for spinal anaesthesia in LSCS. The study will compare the onset and duration of sensory and motor block, intraoperative hemodynamic parameters and post operative analgesic requirement. Secondary objective of the study will be to compare the levels of sedation, and associated side effects with the 2 drugs. |