| CTRI Number |
CTRI/2025/01/079107 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of precautionary dose of intravenous bolus versus infusion dose of phnylephrine for prevention of spinal anaesthesia induced hypotension in elective cesarean section |
|
Scientific Title of Study
|
Comparison of prophylactic intravenous bolus versus infusion of phenylephrine for preventing spinal anesthesia-induced hypotension in elective cesarean sections |
| 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 Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
sgrdanaesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
sgrdanaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9464231286 |
| Fax |
|
| Email |
sakshikoundal54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar |
|
|
Primary Sponsor
|
| Name |
SGRD |
| Address |
Department of Anaesthesia, Sri Guru Ram Das institute of medical Sciences and Research, Amritsar, 143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RUCHI GUPTA |
SGRD |
Gynea OT, Sri Guru Ram Das Institute of Medical
Sciences and Research, Amritsar
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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 |
| Comparator Agent |
phenylephrine |
Group A: Continuous iv infusion of phenylephrine at 0.15mcg/kg/min started
immediately after spinal block
Group B: Single dose of phenylephrine ,50mcg iv administered immediately after spinal block |
| Intervention |
Spinal Anaesthesia |
The Spinal Anaesthesia will be given after
confirming free flow of CSF 0.5% heavy bupivacaine 2.4ml will be given . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All the patients who are undergoing cesarean section or the patients falling under
American Society of Anesthesiology (ASA) Grade II |
|
| ExclusionCriteria |
| Details |
1. Contraindications to regional anesthesia such as anatomic disorders of spine, shock,
local site infections, peripheral neuropathy.
2. Patients with the history of hypertension or pregnancy induced hypertension.
3.Patients with hypersensitivity to study drugs .
4.Patients with coagulation disorders and bleeding disorders.
5.Patients with cardiovascular or cerebrovascular disorders
6. Patients with fetal abnormality |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the effect of
prophylactic doses of intravenous bolus versus infusion of phenylephrine for prevention
of spinal induced hypotension in elective cesarean section.
|
Continuous intraoperative, vitals will be recorded every 2min interval for first 10min and then at 5 min interval till the end of surgery. outcome will also be assessed in post anaesthetic care unit (PACU) at
15min interval.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess intaoperative complications related to study drug.
To calculate apgar scoreat 1 and 5 minute respectively. |
Throughout during the surgery and APGAR score will be assessed immidiatly and after 5 minutes of birth |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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 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
|
INTRODUCTION: Spinal block is the preferred choice of anesthesia for cesarean
sections due to its efficacy and safety profile. However, it can lead to sympathetic
nerve block, reducing peripheral vascular resistance and causing hypotension. Various
interventions can be employed to correct this hypotension, such as adjusting the dose
of the anesthetic agent, and administering vasoactive medications. Phenylephrine is
the first-line drug used to manage hypotension resulting from spinal anesthesia.
AIM: To evaluate the effect of prophylactic doses of intravenous bolus versus infusion
of phenylephrine for the prevention of spinal-induced hypotension in elective cesarean
sections. Objective of the study is to compare the effectiveness of prophylactic
intravenous bolus versus infusion of phenylephrine in preventing spinal-induced
hypotension in elective cesarean sections.
METHODOLOGY: An interventional, open label study will be conducted on all
patients who are undergoing lower segment cesarean section from July 2024 to
December 2025 will be devided in to two groups i.e. Group A will receive continuous
IV infusion of phenylephrine at 0.15 mcg/kg/min and Group B will recieve Single IV
bolus dose of phenylephrine 50 mcg.
SIGNIFICANCE: This study aims to determine the most effective prophylactic
administration method of phenylephrine for preventing spinal-induced hypotension in
elective cesarean sections, thus improving maternal and fetal outcomes. |