Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal An… (NCT05574257) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
South Korea82 participantsStarted 2022-02-01
Plain-language summary
After dividing the patients into two groups, sedation is performed with propofol and remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature change after surgery.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
* American Society of Anesthesiologists' physical status class (ASA) award class I-III.
Exclusion Criteria:
* Patients with fever before surgery
* Patients taking antipyretics before surgery
* Patients who are chronically using anti-inflammatory drugs
* High-risk patients with ASA class IV or higher
* Patient who refused sedation
* Patients with thyroid dysfunction.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared remimazolam and propofol for sedation during spinal anesthesia — if I need a procedure under spinal anesthesia for a lower extremity, gynecologic, or urinary tract condition, which of these two sedatives would my care team plan to use, and does the research from this trial influence that decision?
2The trial focused on perioperative hypothermia — which means a drop in body temperature during or right after surgery — how serious is that risk for the type of procedure I'm having, and what steps would be taken to prevent or manage it?
3Since this study has already been completed, have the results been published or shared anywhere, and can you walk me through what they found about which sedative better protected against hypothermia?
4This trial was labeled 'Phase NA,' which often means it was observational or comparative rather than testing a brand-new treatment — does that mean both remimazolam and propofol are already considered standard options, and how does that affect which one you'd recommend for me?
5Beyond the choice of sedative, are there other factors specific to my condition or health history that might put me at higher risk for hypothermia during surgery, and how would you monitor and respond to that during my procedure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.