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Effect of Lidocaine Through Gastric Tube on PONV

9. juni 2026 opdateret af: General Hospital of Ningxia Medical University

Effect of Lidocaine Applied Via Nasogastric Tube on Postoperative Nausea and Vomiting in Obese Patients Undergoing Bariatric Surgery

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Postoperative nausea and vomiting (PONV) is a common complication following bariatric surgery, with incidence rates reaching up to 30-80%. In bariatric surgical patients, the burden of PONV is particularly high due to multiple risk factors, including surgical trauma to upper GI system, frequent opioid use, increased intra-abdominal pressure, altered gastric anatomy, and heightened sensitivity of gastrointestinal reflex pathways. Effective prevention and treatment of PONV in this population therefore represents a major clinical priority.

Current prophylactic strategies rely primarily on pharmacological agents such as serotonin (5-HT3) receptor antagonists, corticosteroids, dopamine antagonists, and multimodal combinations. Despite these measures, the incidence of breakthrough PONV remains significant, underscoring the need for additional safe, effective, and inexpensive interventions.

Lidocaine, traditionally used as a local anesthetic and antiarrhythmic, has gained attention in perioperative medicine for its systemic anti-inflammatory, analgesic, and opioid-sparing effects when administered intravenously. Evidence suggests that perioperative lidocaine can improve gastrointestinal motility, reduce visceral hypersensitivity, and facilitate earlier return of bowel function. These properties raise the possibility that lidocaine may also influence nausea and vomiting pathways by attenuating vagal afferent signaling, reducing local gastric irritation, and dampening inflammatory responses within the gastrointestinal mucosa.

Delivering lidocaine directly into the gastric cavity via an orogastric (OG) tube represents a novel and pragmatic approach. Unlike intravenous administration, intragastric instillation allows targeted mucosal exposure, potentially reducing afferent vagal stimulation that triggers nausea and vomiting. This method is technically simple, inexpensive, and feasible within the routine workflow of bariatric surgery, as OG tubes are already placed for intraoperative management.

This study aims to evaluate whether the administration of lidocaine via nasogastric tube can reduce the incidence of postoperative nausea and vomiting (PONV) in patients undergoing bariatric surgery. If effective, local lidocaine administration may serve as a simple, low-cost, and readily adoptable strategy to improve postoperative outcomes in bariatric surgery patients. This approach could expand the multimodal anesthesia regimen and optimize the enhanced recovery after surgery (ERAS) pathway for bariatric procedures.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Ningxia
      • Yinchuan, Ningxia, Kina, 750000
        • Rekruttering
        • General Hospital of Ningxia Medical University
        • Kontakt:
          • General Hospital of Ningxia Medical University
          • Telefonnummer: +86-0951-4091488
          • E-mail: 1342850868@qq.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lidocaine
Lidocaine is administered via a gastric tube.
Procedure: Lidocaine
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.
Eksperimentel: Normal Saline
Administer normal saline through the gastric tube.
Procedure: Normal Saline (0.9% NaCl)
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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Degree of postoperative nausea and vomiting
Tidsramme: 6 hours, 12 hours, and 24 hours after surgery
The severity of nausea and vomiting was assessed using the Numerical Rating Scale at 6 hours, 12 hours, and 24 hours after surgery, respectively. A score of 0 indicated no nausea or vomiting, and a score of 10 indicated the most severe nausea or 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.
Tidsramme: Within 24 hours after the operation
Within 24 hours after the operation
Use rescue antiemetics
Tidsramme: Within 24 hours after surgery.
Use of emergency antiemetic drugs and time nodes after surgery.
Within 24 hours after surgery.
Opioid use within 24 hours after surgery
Tidsramme: 24 hours after surgery
The amount of opioids used 24 hours after surgery.
24 hours after surgery
Time of first tolerable oral intake
Tidsramme: Within 72 hours after surgery.
The time of the first oral tolerance to eating after surgery
Within 72 hours after surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

General Hospital of Ningxia Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Siying He-2026-01

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Kliniske forsøg med PONV

Kliniske forsøg med Lidocaine

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