Skip to content

Evaluation of Post-Induction Hypotension Treatment with PRAM Method

Evaluation of Post-Induction Hypotension Treatment with PRAM Method Data in Gynecologic Oncology Cases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06787404
Enrollment
100
Registered
2025-01-22
Start date
2024-03-01
Completion date
2025-04-01
Last updated
2025-03-05

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

Conditions

Hypotension on Induction

Keywords

Post-induction Hypotension, PRAM, Ephedrine, Noradrenaline

Brief summary

The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases. The goal of this observational study is to compare post-induction hypotension treatments with PRAM method in Gynecologic Oncological Cases.

Detailed description

Post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. The global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. Post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. However, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes. For this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the MostCare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. This investigation focuses on patients experiencing a mean arterial pressure \<65 mmHg or a \>30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. Additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.

Interventions

DRUGEphedrine

5 milligrams of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.

5 micrograms of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Above 18 years old * Operated for Gynecologic Oncological reasons * BMI\<35

Exclusion criteria

* Refusal to participate in the study * Additional spinal or epidural anesthesia * Dementia patients from whom consent could not be obtained * Atrial fibrillation with a rapid ventricular response * Patients with difficult ventilation and/or difficult intubation * Left ventricular ejection fraction (EF) below 30% * Severe aortic valve stenosis * Obesity (BMI \>35) * Chronic beta-blocker use

Design outcomes

Primary

MeasureTime frameDescription
Is there a difference in the need for repeated doses of treatments to reach the target blood pressure in patients who develop post-induction hypotension?First 30 minutes after anesthesia induction or time to skin incisionWhen hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment
Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?First 30 minutes after anesthesia induction or time to skin incisionWhen hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed that is there a difference in the time to reach the target blood pressure after treatments

Secondary

MeasureTime frameDescription
Cardiac Output (CO)First 30 minutes after anesthesia induction or time to skin incisionTo examine the effects of the applied treatments on the CO from the PRAM method and compare them with each other.
Systemic vascular resistance (SVR)First 30 minutes after anesthesia induction or time to skin incisionTo examine the effects of the applied treatments on the systemic vascular resistance from the PRAM method and compare them with each other.
Cardiac Cycle Efficiency (CCE)First 30 minutes after anesthesia induction or time to skin incisionTo examine the effects of the applied treatments on the CCE from the PRAM method and compare them with each other.
Stroke Volume (SV)First 30 minutes after anesthesia induction or time to skin incisionTo examine the effects of the applied treatments on the SV from the PRAM method and compare them with each other.
Arterial Elastance (Ea)First 30 minutes after anesthesia induction or time to skin incisionTo examine the effects of the applied treatments on the Ea from the PRAM method and compare them with each other.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026