Evaluation of Post-Induction Hypotension Treatment with PRAM Method

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypotension on Induction
• Intervention / Treatment: Drug: Ephedrine; Drug: Noradrenalin

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06660
    • Ankara Bilkent Sehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The investigators choose Gynecological Oncology patients who will operated for gyno-oncological reasons

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ephedrine; When post-induction hypotension occurred patients were treated with 5 milligrams ephedrine in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment.	Drug: Ephedrine; 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
Noradrenaline; When post-induction hypotension occurred patients were treated with 5 micrograms noradrenaline in this group. If blood pressure does not reach desired levels, same dosage will be repeated 5 minutes later from administration. Maximum 3 doses will be applied and if hypotension ist persist the treatment will changed to rescue treatment.	Drug: Noradrenalin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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?"	When hypotension is occured, researchers applied two treatment (e.g. Ephedrine and Norepinephrine) and assessed how many hypotension episodes occured after treatment	First 30 minutes after anesthesia induction or time to skin incision
"Is there a difference in the time to reach the target blood pressure after treatments in patients who develop post-induction hypotension?"	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	First 30 minutes after anesthesia induction or time to skin incision

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Akgün E Şarer, Ass. Prof., Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ephedrine; Noradrenaline; PRAM; Post-induction Hypotension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Central Nervous System Stimulants; Bronchodilator Agents; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Norepinephrine; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: E2-23-5996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No