| CTRI Number |
CTRI/2024/09/073765 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Medications to Manage Low Blood Pressure After Spinal Anesthesia in Planned C-Sections |
|
Scientific Title of Study
|
PHENYLEPHRINE INFUSION WITH MEPHENTERMINE INFUSION FOR MANAGEMENT OF HYPOTENSION FOLLOWING SPINAL ANAESTHESIA FOR ELECTIVE CAESAREAN DELIVERY: A COMPARATIVE STUDY |
| 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 Shivani Rathee |
| Designation |
Associate Professor |
| Affiliation |
SGT Medical College |
| Address |
Department of Anaesthesia, SGT Hospital,Budhera
Department of Anaesthesia, SGT Hospital,Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9812431490 |
| Fax |
|
| Email |
vp.ratheeclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Rathee |
| Designation |
Associate Professor |
| Affiliation |
SGT Medical College |
| Address |
Department of Anaesthesia, SGT Hospital,Budhera
Department of Anaesthesia, SGT Hospital,Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
9812431490 |
| Fax |
|
| Email |
vp.ratheeclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Utsav Patel |
| Designation |
Post Graduate student |
| Affiliation |
SGT Medical College |
| Address |
Department of Anaesthesia, SGT Hospital,Budhera
Department of Anaesthesia, SGT Hospital,Budhera
Gurgaon
HARYANA
122505
India |
| Phone |
8347628715 |
| Fax |
|
| Email |
utsav4413@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, OT Complex, SGT Medical College and Hospital, Budhera , Gurugram-122505, Haryana, India |
|
|
Primary Sponsor
|
| Name |
SGT Hospital |
| Address |
Department of Anaesthesia, SGT Hospital,Budhera,Gurugram, Haryana-122505, India |
| 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 Utsav Patel |
SGT Medical College and Hospital |
Department of Anaesthesia, OT Complex, Room no-02, Sgt Hospital, Budhera, Gururgram, Haryana
Gurgaon
HARYANA |
8347628715
utsav4413@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, FMHS, SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mephentermine infusion following spinal anaesthesia for elective caesarean delivery |
After administration of spinal anaesthesia using 25G Quincke needle at L3-L4 or L4-L5 intervertebral space and 2.2ml of 0.5% hyperbaric bupivacaine, mephentermine given in a concentration of 300mcg/ml @ 1ml/min. |
| Intervention |
Phenylephrine infusion following spinal anaesthesia for elective caesarean delivery |
After administration of spinal anaesthesia using 25G Quincke needle at L3-L4 or L4-L5 intervertebral space and 2.2ml of 0.5% hyperbaric bupivacaine, phenylephrine given in a concentration of 25mcg/ml @ 1ml/min. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 or 2 |
|
| ExclusionCriteria |
| Details |
ASA 3 or 4
Pt. with placental complications
H/o pre-eclampsia
Infection at the site of SPINAL needle penetration
Coagulopathies
Existing neurological diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of effect of phenylephrine and mephentermine on NIBP, SBP, DBP and HR. |
Haemodynamic parameters will be recorded-
every 2 minutes for the first 15 minutes,
then every 5 minutes till the completion of Surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse total number of boluses required to maintain BP within 20% of baseline. |
Variable-as per patient requirement |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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 - NO
|
|
Brief Summary
|
The study aims to compare the effectiveness of phenylephrine infusion versus mephentermine infusion in managing hypotension following spinal anaesthesia during elective caeserean delivery. Key objectives include evaluating the impact of each drug on non-invasive blood pressure, Systolic blood pressure, diastolic blood pressure. The study also seeks to compare the incidence of side effects and the total number of boluses required to maintain blood pressure within 20% of baseline levels. Outcomes will be assessed at various time points during and after the procedure to determine the relative efficacy and safety of each treatment. |