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Blinded and pre-defined analysis of retrospectively obtained data on treatment of arterial hypotension with Ephedrin, Phenylephrin and a 20:1 combination of Cafedrin/Theodrenalin (Akrinor) in patients undergoing caesarean section under spinal anaesthesia

Blinded and pre-defined analysis of retrospectively obtained data on treatment of arterial hypotension with Ephedrin, Phenylephrin and a 20:1 combination of Cafedrin/Theodrenalin (Akrinor) in patients undergoing caesarean section under spinal anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00012520
Enrollment
772
Registered
2017-11-07
Start date
2012-07-06
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

I95 I95.2

Interventions

Group 1: time period 1: retrospective assessment of patients receiving ephedrine due to arterial hypotension during cesarean section und spinal anaesthesia. Group 2: time period 2: retrospective asses

Sponsors

Klinik für Anästhesie und Intensivtherapie der Philipps-Universität Marburg
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 50 Years

Inclusion criteria

Inclusion criteria: - cesarean section performed under spinal anaesthesia between July 2012 and April 2017, - arterial hypotension that required pharmacological stabilization according to the decision of the attending anesthesiologist

Exclusion criteria

Exclusion criteria: emergency section performed under general anaesthesia

Design outcomes

Primary

MeasureTime frame
A) endpoints with respect to the parturient: symptomatic alterations of haemodynamics associated with symptoms like dizziness, nausea, vomiting, clouding of consciousness, unconsciousness, palpitation - data recording was performed retrospectively (chart review) - B) endoints with respect to the fetus/newborn: - pH in the umbilical cord - BE in the umbilical cord (BE=base excess) - data recording was performed retrospectively (chart review) -

Secondary

MeasureTime frame
A) secondary endpoint with respect to the parturient: - lowest heart rate documented - incidence of bradycardia (new definition adopted for pregnat femals undergoing cesarean section; heart rate 110 bpm) - incidence of pharmacological interventions to treat bradycardia, e.g. administration of atropine, orciprenalin, epinephrine - incidence of pharmacological interventions to treat tachycardia, e.g. administration of beta-blocker - incidence of pharmacological interventions to treat persistent hypotension, e.g. administration of a second/alternative catecholamine besides the initial treatment with Akrinor, ephedrin, or phenylephrine respectively - numbers of boluses of Akrinor/Ephedrin/phenylephrine until a mean arterial pressure of at least 70 mmHg is restored - Excessive raise of arterial blood pressure (defined as mean arterial pressure > 100 mmHg B) secondary endpoint with respect to the fetus/newborn: - incidence of acidoses (defined as pH 10 mmol) - APGAR-score 1,5,10 min after cutting the umbilical cord C) Explorative data analysis: further descriptive analyses are planned to create hypotheses, mainly focusing on efficacy and efficiency parameters, e.g. time until 10, 20, 30 percent increase of arterial blood pressure are reached. Data analysis on blood pressure will be performed with MAP (mean arterial pressure) that is provided from the automated blood pressure measurement system. If such an automated measurement is not available MAP will be calculated according to the formula: MAP = (RRsyst. + 2xRRdiast.) / 3 - data recording was performed retrospectively (chart review)

Countries

Germany

Contacts

Public ContactLeopold Eberhart

Klinik für Anästhesie und Intensivtherapie der Philipps-Universität Marburg

eberhart@staff.uni-marburg.de06421 58 62945

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 3, 2026