Clinical trial

Effect of Lidocaine Through Gastric Tube on PONV

Recruiting now · Not applicable · 1 countries · Registry ID NCT07643298

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionPONV

Full registry criteria

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.

Treatments and study arms

Lidocaine

Procedure

Upon completion of the surgery and before extubation, 20 ml of 0.5% lidocaine should be administered through the pre - inserted orogastric tube. The gastric tube should be clamped for 5 minutes to ensure sufficient mucosal exposure, and then removed before extubation.

Normal Saline (0.9% NaCl)

Procedure

Before extubation after the surgery is completed, administer 20 ml of normal saline through the pre - inserted orogastric tube. Clamp the gastric tube for 5 minutes to ensure sufficient mucosal exposure, and then remove the tube before extubation.

Primary outcomes

The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery.Within 24 hours after the operation

Study locations

1 locations were listed when this page was built. The first 40 are shown.

General Hospital of Ningxia Medical University🇨🇳 Yinchuan, Ningxia, China

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General Hospital of Ningxia Medical UniversityContact

Email · Call +86-0951-4091488