Evaluation of Post-Induction Hypotension Treatment with PRAM Method

NCT ID: NCT06787404

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-04-01

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.

Conditions

Hypotension on Induction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ephedrine

Intervention Type: 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.

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.

Noradrenalin

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ephedrine Group; Noradrenalin Group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akgün E Şarer, Ass. Prof.

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E2-23-5996

Identifier Type: -

Identifier Source: org_study_id