Clinical trial NCT06787404: Evaluation of Post-Induction Hypotension Treatment with PRAM Method
Official title: Evaluation of Post-Induction Hypotension Treatment with PRAM Method Data in Gynecologic Oncology Cases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypotension on Induction
Keywords: Post-induction Hypotension
PRAM
Ephedrine
Noradrenaline
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators choose Gynecological Oncology patients who will operated for gyno-oncological reasons

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.

Eligibility criteria: 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

Primary outcomes:
measure: "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?"
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
measure: "Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
Secondary outcomes:
measure: Systemic vascular resistance (SVR)
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
measure: Arterial Elastance (Ea)
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
measure: Cardiac Output (CO)
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
measure: Stroke Volume (SV)
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
measure: Cardiac Cycle Efficiency (CCE)
timeFrame: First 30 minutes after anesthesia induction or time to skin incision
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Akgün E Şarer, Ass. Prof.
role: STUDY_DIRECTOR
References: