Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane (NCT04865991) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane
Indonesia40 participantsStarted 2017-09-01
Plain-language summary
This study was an experimental, single-blinded, randomized controlled trial that aimed to compare recovery time between TCI propofol and sevoflurane. After ethical approval from Research Ethical Committee Faculty of Medicine, Universitas Indonesia (879/UN2.F1/ETIK/2017) and informed consent, patients aged 18-65 years old, body mass index 18 - 30 kg/m2, American Society of Anesthesiologists (ASA) status I-II who were scheduled for vitrectomy surgery under general anesthesia, at Kirana's Eye Operating Theatre Cipto Mangunkusumo National Referral Hospital from September until December 2017, were recruited in this study. All subjects would be recruited with a consecutive sampling method and randomly assigned into two groups, the TCI propofol group and sevoflurane group. Block random allocation was done for all subjects by using the random allocator program Winpepi.
Who can participate
Age range
18 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:
* patients aged 18-65 years old
* body mass index 18 - 30 kg/m2
* American Society of Anesthesiologists (ASA) status I-II
* scheduled for vitrectomy surgery under general anesthesia
Exclusion Criteria:
* Patients with hemodynamic instability, allergy, raised intracranial pressure, and a history of hyperthermia malignant
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 two types of anesthesia — propofol given through a controlled IV pump and sevoflurane gas — for eye surgery related to vitreous detachment; which of these approaches does my surgical team currently use, and is there any reason one might be safer or more comfortable for me specifically?
2Since this trial was completed and focused on measuring recovery time, has my doctor seen or reviewed any results showing whether one anesthesia method led to patients waking up faster or feeling better after surgery for vitreous detachment?
3Propofol TCI involves a computer-controlled IV infusion while sevoflurane is an inhaled gas — are there side effects or risks with either method I should know about, especially related to nausea, dizziness, or confusion after eye surgery?
4This study was listed as Phase NA, meaning it was comparing existing anesthesia techniques rather than testing a new drug — does that change how confident my doctor is in the safety profile of both options for my situation?
5If the results from this trial suggest one anesthesia method leads to quicker recovery, would that actually make a meaningful difference in my day, such as how long I stay in the recovery room or when I can safely go home after vitreous detachment surgery?
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.