Effect of Lidocaine Through Gastric Tube on PONV (NCT07643298) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Lidocaine Through Gastric Tube on PONV
China100 participantsStarted 2026-05-20
Plain-language summary
The goal of this clinical trial is to learn if intragastric administration of lidocaine can reduce postoperative nausea and vomiting in obese patients undergoing laparoscopic sleeve gastrectomy. The main question it aims to answer is:
Does administering 0.5% lidocaine via an orogastric tube reduce the incidence of postoperative nausea and vomiting (PONV) in the post-anesthesia care unit and within the first 24 hours after surgery compared to a placebo (normal saline)?
Researchers will compare the Lidocaine Group to the Placebo Group to see if the intervention lowers the PONV incidence.
Participants will:
* Receive the assigned study solution (either 0.5% lidocaine 20ml or normal saline 20ml) through an orogastric tube upon surgery completion and before extubation.
* Have their gastric tube clamped for 5 minutes to ensure mucosal exposure before removal.
* Undergo standardized total intravenous anesthesia and perioperative management according to the study protocol.
* Be assessed for nausea, vomiting, and other outcomes at specified time points postoperatively in the recovery room and at 6, 12, and 24 hours.
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:
* Adults aged between 18 and 65 years old;
* American Society of Anesthesiologists (ASA) physical status classification II - III;
* Planned to undergo primary elective laparoscopic sleeve gastrectomy with general anesthesia;
* Capable of giving informed consent.
Exclusion Criteria:
* Known allergy, hypersensitivity or contraindication to lidocaine or amide - type local anesthetics;
* Previous significant liver or kidney dysfunction (e.g., ALT/AST \> 3 times the upper limit of normal, GFR \< 30 mL/min);
* History of epilepsy, cardiac conduction abnormalities or previous diagnosis of malignant hyperthermia;
* Pregnancy or lactation;
* Patients who received systemic lidocaine treatment during the operation;
* History of severe postoperative nausea and vomiting (PONV) or motion sickness, requiring multiple prophylactic medications;
* Emergency or revision bariatric surgery.
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
The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery.
Timeframe: Within 24 hours after the operation
Trial details
NCT IDNCT07643298
SponsorGeneral Hospital of Ningxia Medical University