A clinical study to compare three doses of the drug phenylephrine to prevent fall in blood pressure in pregnant female undergoing caesarean section

Comparison of three different phenylephrine infusion regimens in preventing maternal hypotension in parturients undergoing caesarean section under spinal anaesthesia: A double-blind, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013823

Enrollment

Registered

2018-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Phenylephrine infusion at the rate of 70mcg/min: started immediately after administration of spinal anaesthesia Intervention2: Phenylephrine bolus 50mcg i/v: Phenylephrine bolus of 50mc

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA class 1 and 2 pregnant women 2. Gestation age >36 weeks 3. Singleton gestation 4. Scheduled for elective caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. ASA class 3 and 4 3. Pregnant women in labor 4. Body Mass Index >40kg/metre square 5. Type-1 Diabetes Mellitus 6. Pre-existing or pregnancy induced hypertension 7. Cardiac or cerebrovascular disease 8. Fetus with severe congenital anomaly/ intra-uterine growth retardation 9. History of monoamine oxidase inhibitor use 10. Allergy to phenylephrine

Design outcomes

Primary

Measure	Time frame
Number of physician interventions needed- 1. to maintain maternal systolic blood pressure within 20% of baseline or 90mm Hg 2. to treat bradycardia (heart rate 50beats/min)Timepoint: Non-invasive blood pressure was recorded every minute after spinal anaesthesia till delivery and then every 2 minutes till 10 minutes after delivery	—

Secondary

Measure	Time frame
Incidence of fetal acidosis (pH less than 7.2)Timepoint: Umbilical arterial blood gases were analysed from double clamped umbilcal cord;Incidence of intra-operative nausea and vomitingTimepoint: From immediately after spinal anaesthesia till 10 minutes after delivery;Neonatal Apgar ScoreTimepoint: At 1 minute and 5 minutes after delivery	—

Countries

India

Contacts

Public ContactGaurav Kuthiala

Satguru Partap Singh Hospitals

paindocgk@gmail.com09814141428

Outcome results