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Hypotension prediction index to prevent spinal hypotension

Hypotension prediction index guided Proactive norepinephrine bolus compare with prophylaxis norepinephrine infusion to prevent spinal hypotension in cesarean delivery patient: A randomized controlled trial

Status
Unknown
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20230707009
Enrollment
127
Registered
2023-07-07
Start date
2023-07-24
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

Term pregnancy patient who schedule for cesarean delivery under spinal anesthesia Cesarean delivery Spinal hypotension Hypotension prediction index

Interventions

Norepinephrine bolus is administered based on hypotension prediction index as a proactive treatment,Norepinephrine infusion is administered 0.05mcg kg min immediate after spinal anesthesia. Interim
Prevention,Prevention
HPI group,NIBP group

Sponsors

Ramathibodi hospital, Mahidol University
Lead Sponsor
Edward life Sciences
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Term singleton pregnancy 2. Elective cesarean delivery 3. American Society of Anesthesiology classification 2 or 3

Exclusion criteria

Exclusion criteria: 1. Hypertensive disorder 2. Gestational age less than 37 wks 3. failed spinal anesthesia 4. Cardiovascular disorder and contraindication for spinal anesthesia 5. Contraindication for finger cuff Acumen

Design outcomes

Primary

MeasureTime frame
Incidence of spinal hypotension 10 minute after delivery incidence

Secondary

MeasureTime frame
Time weighted average MAP less than 65 mmHg end of surgery area under the curve,AUC MAP less than 65 mmHg-min end of surgery Area under the curve,Duration of MAP less than 65 mmHg end of surgery time,Time weighted average MAP less than 55 mmHg end of surgery area under the curve,AUC MAP less than 55 mmHg end of surgery area under the curve,Duration of MAP less than 55 mmHg end of surgery time

Countries

Thailand

Contacts

Public ContactLisa Sangkum

Ramathibodi hospital, Mahidol university

lisa.sangkum@gmail.com0989075899

Outcome results

None listed

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