| CTRI Number |
CTRI/2025/09/094870 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing Calcium Gluconate and Phenylephrine to prevent occurrence of low blood pressure after spinal anaesthesia in women having planned caesarean section deliveries. |
|
Scientific Title of Study
|
Comparison of Calcium Gluconate and Phenylephrine for prevention of post spinal hypotension in parturients undergoing elective caesarean 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 |
Dr Radhika Thakur |
| Designation |
Post graduate resident |
| Affiliation |
VMMC and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
7428404554 |
| Fax |
|
| Email |
radhika.thakur75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Saini |
| Designation |
Director Professor |
| Affiliation |
VMMC and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Thakur |
| Designation |
Post graduate resident |
| Affiliation |
VMMC and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
7428404554 |
| Fax |
|
| Email |
radhika.thakur75@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care,VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi, Delhi 110029 |
| 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 Radhika Thakur |
Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, VMMC and SJH, Ansari Nagar West, New Delhi, Delhi, 110029
South
DELHI |
7428404554
radhika.thakur75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and SJH Institutional Ethics Committee |
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 |
Calcium Gluconate |
10mL of 10% Inj. Calcium Gluconate with 40 mL Normal Saline infused intravenously over 15 minutes prior to induuction with spinal anaesthesia |
| Comparator Agent |
Phenylephrine |
Inj Phenylephrine 50 mcg with 49mL Normal Saline infused intravenously over 15 minutes prior to induction with spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Term parturients between 18-40 years of age belonging to American Society of Anesthesiologists (ASA) Grade II and III scheduled to undergo elective caesarean section under subarachnoid block
2. Height between 150-170 cms
3. BMI less than 30 kg/m2
4. Singleton pregnancy
|
|
| ExclusionCriteria |
| Details |
Patients with-
1. Contraindications for regional anaesthesia like allergy to local anaesthetic drugs, local site infection or with coagulopathies
2. Inability to communicate effectively/ known psychiatric illness
3. Antepartum Haemorrhage and Pre-eclampsia/essential hypertension
|
|
|
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 compare the incidence and severity of post-spinal hypotension between intravenous Calcium Gluconate and Phenylephrine in parturients undergoing elective caesarean section, using serial systolic blood pressure measurements. Hypotension will be defined as SBP less than 90 mm Hg or more than or equal to 20% decrease from baseline. |
Every 2 minutes for 10 minutes, then every 5 minutes until end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic Parameters which include
Heart Rate (HR)
Diastolic Blood Pressure (DBP)
Mean Arterial Pressure (MAP)
|
Every 2 minutes for 10 minutes, then every 5 minutes until end of surgery |
| Estimate intraoperative blood loss using gravimetric and visual method. |
|
Level of maximum Sensory blockade and
Level of Motor blockade using Modified Bromage Scale |
|
Neonatal Outcomes
APGAR Scores |
At 1 minute and 5 minutes post delivery |
| Umbilical Artery Blood gas analysis to assess fetal well being and effects of maternal drug intervention on the neonate |
|
Maternal Serum Calcium Levels
|
Preoperative (baseline)
Postoperative (at skin closure) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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 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
|
Post-spinal hypotension is a frequent complication during caesarean section, associated with maternal and fetal morbidity. Phenylephrine is the standard vasopressor for prophylaxis but may cause reflex bradycardia and reduced cardiac output. Calcium gluconate, through vasoconstriction, positive inotropy, and volume expansion, may offer a safer alternative.
This study is a prospective, randomized, double-blind, comparative interventional trial conducted on 70 ASA II/III term parturients undergoing elective caesarean section under subarachnoid block at VMMC & Safdarjung Hospital, New Delhi. Participants will be randomly allocated into two groups: Calcium Gluconate group (10 mL of 10% calcium gluconate in 40 mL NS infused over 15 minutes) and Phenylephrine group (50 mcg phenylephrine in 49 mL NS infused over 15 minutes).
The primary outcome is incidence of post-spinal hypotension.
The secondary outcomes include additional vasopressor requirement, intraoperative blood loss, maternal hemodynamic parameters, neonatal Apgar scores, umbilical artery pH and ionized calcium levels.
The study duration is 18 months, with a total sample size of 70 (35 per group). |