Comparison of Remifentanil-induced Postoperative Hyperalgesia Between Patients From Plain Area an… (NCT05028049) | Clinical Trial Compass
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Comparison of Remifentanil-induced Postoperative Hyperalgesia Between Patients From Plain Area and Plateau Area
China160 participantsStarted 2021-08-30
Plain-language summary
Purpose:
1. To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas
2. To compare the peri-operative analgesic requirements of patients in plain and plateau areas
Who can participate
Age range
20 Years – 60 Years
Sex
FEMALE
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
. Subject is scheduled to undergo gynecological laparoscopic surgery under a short general anesthesia of less than 2 hours
. Subject's American Society of Anesthesiologists physical status is I-II.
. The subject's parent/legally authorized guardian has given written informed consent to participate.
. Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.
Exclusion criteria
. Subject has a diagnosis of renal or liver failure.
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
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
Timeframe: 48 hours after surgery
Trial details
NCT IDNCT05028049
SponsorTianjin Medical University General Hospital
. Subject has a diagnosis of Insulin dependent diabetes.
. Subject is allergy and contraindication to any drugs used during general anesthesia.
. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
. Subject has any contraindication for the use of patient-controlled analgesia (PCA).