Using propofol for anesthesia induction in high-risk patients
Does Induction of Anesthesia with Target-controlled Propofol Infusion Reduce the Risk of Post-induction Hypotension in High-risk Patients?
This study is testing whether using a special method to give propofol for anesthesia can help high-risk patients avoid low blood pressure during major surgeries compared to the usual way of giving it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Acibadem University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06535230 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the incidence of hypotension following anesthesia induction in high-risk patients using a target-controlled infusion (TCI) of propofol versus standard manual induction techniques. It focuses on patients with higher American Society of Anesthesiologists (ASA) risk scores, who are more susceptible to hypotension during anesthesia. The study builds on previous findings that suggest TCI may reduce the risk of hypotension compared to traditional methods. Participants will undergo major elective surgeries and will be monitored closely for blood pressure changes during the induction process.
Who should consider this trial
Good fit: Ideal candidates are patients classified as ASA physical status 3-4 who are undergoing major elective surgery and require intra-arterial blood pressure monitoring.
Not a fit: Patients who are under 18 years of age, have lower ASA physical status scores, or present with certain medical conditions such as severe valvular heart disease or drug addiction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of hypotension in high-risk patients during anesthesia induction.
How similar studies have performed: Previous studies have indicated that target-controlled infusions can reduce hypotension risks, suggesting a promising approach that may be further validated in this high-risk population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with the American Society of Anesthesiology physical status 3-4 * Underwent major elective surgery * Required intra-arterial blood pressure monitoring before induction. Exclusion Criteria: * Under 18 years of age * Patients with the American Society of Anesthesiology physical status 1-2 * Arrhythmia (atrial fibrillation, frequent premature beat) * Severe valvular heart disease * Morbid obesity * Intubation difficulty * Drug addiction * Treatment with opiates * Pregnancy * Emergency surgery
Where this trial is running
Istanbul
- Acibadem Altunizade Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Serap A Aktas Yildirim, MD
- Email: serapaktas79@yahoo.com.tr
- Phone: +905325605077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.