General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia (NCT05907811) | Clinical Trial Compass
CompletedNot Applicable
General Anesthesia and General Anesthesia Combined With Thoracic Epidural Anesthesia
Turkey (Türkiye)60 participantsStarted 2023-06-05
Plain-language summary
This randomized controlled trial investigated whether adding thoracic epidural analgesia to general anesthesia affects intraoperative neuromuscular blockade and opioid requirements in patients undergoing gastric cancer surgery. Sixty ASA I-II patients aged 18-65 years were randomized to receive either general anesthesia alone (GA, n=30) or general anesthesia with thoracic epidural analgesia (GAE, n=30). Neuromuscular blockade was induced with rocuronium and monitored quantitatively using train-of-four (TOF) stimulation. The primary outcome was the time from TOF 25% to TOF 90% recovery (DUR25-90). Secondary outcomes included supplemental neuromuscular blocker requirements, intravenous opioid consumption, postoperative pain scores, and adverse events. The study was completed in January 2024.
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 Age 18-65 years ASA physical status I-II Scheduled for elective open gastric cancer surgery Exclusion Criteria Severe cardiac, pulmonary, hepatic, or renal disease Coagulopathy or bleeding diathesis Local infection at epidural insertion site Allergy to study medications Electrolyte or acid-base disturbances Chronic use of anticonvulsants, antiarrhythmics, or cholinesterase inhibitors Pregnancy Refusal to participate Contraindications to thoracic epidural analgesia
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Duration of recovery from TOF 25% to TOF 90% (DUR25-90)
Timeframe: During surgery, from administration of the initial intubating dose of rocuronium until recovery to train-of-four ratio 90% (up to 6 hours)