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Active Not RecruitingNCT06787404

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
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGEphedrine5 milligrams of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.
DRUGNoradrenalin5 micrograms of ephedrine will be applied when post-induction hypotension occured. After 3 doses, dose will be increased or changed to other treatment options.

Timeline

Start date
2024-03-01
Primary completion
2024-12-01
Completion
2025-04-01
First posted
2025-01-22
Last updated
2025-03-05

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06787404. Inclusion in this directory is not an endorsement.