Evaluation of Post-Induction Hypotension Treatment with PRAM Method

NCT06787404 | Active Not Recruiting

• 1 other identifier: E2-23-5996
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension on Induction

Keywords

Post-induction Hypotension; PRAM; Ephedrine; Noradrenaline

Outcome Measures

Primary Outcomes (2)

• "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 Outcomes (5)

• Systemic vascular resistance (SVR)

  First 30 minutes after anesthesia induction or time to skin incision

• Arterial Elastance (Ea)

  First 30 minutes after anesthesia induction or time to skin incision

• Cardiac Output (CO)

  First 30 minutes after anesthesia induction or time to skin incision

• Stroke Volume (SV)

  First 30 minutes after anesthesia induction or time to skin incision

• Cardiac Cycle Efficiency (CCE)

  First 30 minutes after anesthesia induction or time to skin incision

Study Arms (2)

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

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

Interventions

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.

Also known as: Ephedrine Group

Ephedrine

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.

Also known as: Noradrenalin Group

Noradrenaline

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since our study is conducted on gynecologic oncology patients, all of our patients are women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Above 18 years old
• Operated for Gynecologic Oncological reasons
• BMI\<35

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, 06660, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Akgün E Şarer, Ass. Prof.

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 22, 2025
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

TU (1)