Effect of Lidocaine Through Gastric Tube on PONV

NCT07643298 | Recruiting DMC

• 1 other identifier: Siying He-2026-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PONV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Degree of postoperative nausea and vomiting

  6 hours, 12 hours, and 24 hours after surgery

• Incidence rates of simple vomiting, simple nausea, and their combination during the postoperative anesthesia recovery room period and within 24 hours after surgery.

  Within 24 hours after the operation

• Use rescue antiemetics

  Within 24 hours after surgery.

• Opioid use within 24 hours after surgery

  24 hours after surgery

• Time of first tolerable oral intake

  Within 72 hours after surgery.

Study Arms (2)

Lidocaine

EXPERIMENTAL

Lidocaine is administered via a gastric tube.

Procedure: Lidocaine

Normal Saline

EXPERIMENTAL

Administer normal saline through the gastric tube.

Procedure: Normal Saline (0.9% NaCl)

Interventions

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.

Lidocaine

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.

Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Siying He

CONTACT

+86 18209610221; 1342850868@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 11, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

CN (1)