NCT06220942

Brief Summary

The value of phenylephrine administration in response to tachycardia in preventing hypotension after spinal anesthesia in elective cesarean section.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

December 22, 2023

Last Update Submit

January 14, 2024

Conditions

Anesthesia

Keywords

Caesarean section , hypotension, spinal anesthesia, phenylephrine

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Hypotension Avoidance of Hypotension Avoidance of Hypotension

    Measure number of hypotensive episodes that would occur after injection of prophylactic phenylephrine for caesarean section ,by spinal anesthesia

    all through the procedure (cesarean section)

Secondary Outcomes (1)

  • Apgar score in neonates. Number of phenylephrine doses. Nausea & vomiting after spinal anesthesia.

    all through the procedure (cesarean section)

Interventions

PhenylephrineDRUG

Pregnant female presented for C.S. after receiving spinal anesthesia, recording the vital data, phenylephrine will be given in a dose of 50 µg IV immediately if the heart rate increases ≥ 20 % of baseline

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant female at childbearing period

You may qualify if:

  • ASA II pregnant female planned for elective C.S., aged between 18 -35 years old.

You may not qualify if:

  • Emergency CS, Complicated CS (Severe bleeding, organ injury, uterine atony), ASA III, VI patients with cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

maha sadek El Derh

Cairo, Heliopolis, 11721, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 24, 2024

Study Start

October 5, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

January 24, 2024

Record last verified: 2024-01

Locations

EG(1)