PONVNCT07643298
Effect of Lidocaine Through Gastric Tube on PONV
A study testing Lidocaine and Normal Saline (0.9% NaCl) in people with PONV, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PONV
- What is being tested?
- Lidocaine and Normal Saline (0.9% NaCl)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000
General Hospital of Ningxia Medical University, +86-0951-4091488, 1342850868@qq.com
About this study
Official title: 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)?
Read more
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.
Read the detailed description
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Lidocaine is administered via a gastric tube. Receives: Procedure: Lidocaine |
| Normal Saline | Experimental | Administer normal saline through the gastric tube. Receives: Procedure: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery.
Measured: Within 24 hours after the operation
Secondary outcomes (5)
Degree of postoperative nausea and vomiting
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.
Measured: 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.
Measured: Within 24 hours after the operation
Use rescue antiemetics
Use of emergency antiemetic drugs and time nodes after surgery.
Measured: Within 24 hours after surgery.
Opioid use within 24 hours after surgery
The amount of opioids used 24 hours after surgery.
Measured: 24 hours after surgery
Time of first tolerable oral intake
The time of the first oral tolerance to eating after surgery
Measured: Within 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start20 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643298
- Sponsor's protocol ID
- Siying He-2026-01
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine Applied Via Nasogastric Tube on Postoperative Nausea and Vomiting in Obese Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07643298
- Acronym / sponsor ID
- Siying He-2026-01
- Conditions
- PONV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Procedure: LidocaineLidocaine is administered via a gastric tube. |
| Normal Saline | Experimental | Procedure: Normal Saline (0.9% NaCl)Administer normal saline through the gastric tube. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineUpon 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. | Procedure or surgery | Lidocaine |
| 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. | Procedure or surgery | Normal Saline |
Primary outcome
The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery.
Time frame: Within 24 hours after the operation
5 secondary outcomes
Degree of postoperative nausea and vomiting
Time frame: 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.
Time frame: Within 24 hours after the operation
Use rescue antiemetics
Time frame: Within 24 hours after surgery.
Opioid use within 24 hours after surgery
Time frame: 24 hours after surgery
Time of first tolerable oral intake
Time frame: Within 72 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Normal Saline (0.9% NaCl) in people with PONV, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siying He (+86 18209610221, 1342850868@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative nausea and vomiting (PONV) in the post - anesthesia care unit and within 24 hours after surgery. (time frame: Within 24 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.