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The maternal cardiovascular effect of phenylephrine-ephedrine compared to ephedrine protocols for cesarean section under spinal anesthesia: a multicenter randomized controlled trial

The maternal cardiovascular effect of phenylephrine-ephedrine compared to ephedrine protocols for cesarean section under spinal anesthesia: a multicenter randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20191210002
Enrollment
316
Registered
2019-12-10
Start date
2019-12-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Hypotension during spinal anesthesia for cesarean secttion

Interventions

if systolic blood pressure less than 80% of baseline&#44
use either phenylephrine or ephedrine according to P/E protocol,if systolic blood pressure less than 80% of baseline&#44
use ephedrine only
Experimental Drug,Experimental Drug
P/E group,control group

Sponsors

None
Lead Sponsor
None,None
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 18 years of age and older scheduled for elective cesarean section in official time 37-42 weeks gestational age ASA physical status I-II normal singleton

Exclusion criteria

Exclusion criteria: multiple gestation complicated pregnancy eg. placenta previa, abruptio placenta preexisting cardiovascular disease, renal and liver impairment, thyroid dysfunction, increased intraocular pressure ongoing infection history of drug abuse, MAOI or TCA group 1 month prior to delivery, vasopressor agent

Design outcomes

Primary

MeasureTime frame
average maternal heart rate after spinal anesthesia until operation end beat per minute

Secondary

MeasureTime frame
average maternal systolic blood pressure after spinal anesthesia until operation end mmHg,severity of nausea and vomiting after spinal anesthesia until operation end score,satisfaction after spinal anesthesia before delivery VAS,total dose of vasopressor after spinal anesthesia until operation end mg, mcg,atropine used after spinal anesthesia until umbilical cord clamping mg,arrhythmia after spinal anesthesia until operation end occurance,Apgar score 1st,5th minutes post-delivery score

Contacts

Public ContactKetchada Uerpairojkit

Faculty of medicine, Chulalongkorn university

ketchada_cc@hotmail.com+66896644730

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026