Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Lidocaine is administered via a gastric tube. |
|
| Normal Saline | Experimental | Administer normal saline through the gastric tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours, 12 hours, and 24 hours after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siying He | Contact | +86 18209610221 | 1342850868@qq.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750000 | China |
Not provided
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 | Use of emergency antiemetic drugs and time nodes after surgery. | Within 24 hours after surgery. |
| Opioid use within 24 hours after surgery | The amount of opioids used 24 hours after surgery. | 24 hours after surgery |
| Time of first tolerable oral intake | The time of the first oral tolerance to eating after surgery | Within 72 hours after surgery. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |