Effect of Lidocaine Through Gastric Tube on PONV
ConditionPONV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGeneral Hospital of Ningxia Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine
Procedure/SurgeryUpon 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/SurgeryBefore 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: LidocaineExperimental treatment 1 intervention
Group B: Normal SalineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 operationSecondary outcomes
1
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.
Time frame
6 hours, 12 hours, and 24 hours after surgery2
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 operation3
Use rescue antiemetics
Use of emergency antiemetic drugs and time nodes after surgery.
Time frame
Within 24 hours after surgery.4
Opioid use within 24 hours after surgery
The amount of opioids used 24 hours after surgery.
Time frame
24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov