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NCT Number: NCT06787404

Evaluation of Post-Induction Hypotension Treatment with PRAM Method

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Bilkent Şehir Hastanesi

Ankara, 06660, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ephedrine

Drug

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.

Other names: Ephedrine Group

Noradrenalin

Drug

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.

Other names: Noradrenalin Group

Primary outcomes

  1. "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?"

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment

  2. "Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    When 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 outcomes

  1. Systemic vascular resistance (SVR)

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    To examine the effects of the applied treatments on the systemic vascular resistance from the PRAM method and compare them with each other.

  2. Arterial Elastance (Ea)

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    To examine the effects of the applied treatments on the Ea from the PRAM method and compare them with each other.

  3. Cardiac Output (CO)

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    To examine the effects of the applied treatments on the CO from the PRAM method and compare them with each other.

  4. Stroke Volume (SV)

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    To examine the effects of the applied treatments on the SV from the PRAM method and compare them with each other.

  5. Cardiac Cycle Efficiency (CCE)

    Time frame: First 30 minutes after anesthesia induction or time to skin incision

    To examine the effects of the applied treatments on the CCE from the PRAM method and compare them with each other.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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