NCT06232785

Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

Application of Remifentanil Target Controlled Infusion Combined With Ibuprofen Injection in Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Second Hospital of Jilin University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare the analgesic effect of sufentanil and ibuprofen and the incidence of vomiting, and to choose better postoperative analgesic drugs for motion sickness patients.in describe participant population. The main questions it aims to answer are: * Whether this anesthesia method can meet the analgesic needs of gynecological laparoscopic surgery. * Whether this anesthesia method can reduce the incidence of nausea and vomiting in patients with motion sickness after gynecological laparoscopic surgery. Participants will use target-controlled infusion anesthesia combined with 0.8g ibuprofen injection. Researchers will compare with use of target-controlled infusion combined with sufentanil to see if the incidence of nausea and vomiting is higher.

Detailed description

Abstract: Objective: To compare the analgesic effect of sufentanil and ibuprofen and the incidence of vomiting, and to choose better postoperative analgesic drugs for motion sickness patients. Methods: Sixty-eight female patients aged between 18 and 60 years with motion sickness were selected for gynecologic endoscopic surgery under general anesthesia. Sixty-eight female patients were randomly divided into two groups, Group B (ibuprofen group) and Group S (sufentanil group), using a random number table method. The initial plasma target concentration of propofol was set at 4ug/ml and adjusted using the titration method. Once the patient lost consciousness, the target concentration of remifentanil was set at 4ng/ml and rocuronium at 0.6mg/kg, followed by endotracheal intubation three minutes later. During the operation, the plasma target concentration of propofol was maintained at 5ug/ml and remifentanil at 4ng/ml, with adjustments made based on stress reaction levels. General anesthesia was sustained through continuous administration of rocuronium at doses of 5 µg/kg/min. In Group B (ibuprofen group), intravenous administration of ibuprofen (0.8g) took place within half an hour before the end of surgery; in Group S (sufentanil group), intravenous injection of sufentanil (0.2ug/kg) occurred half an hour before completion of the operation, along with intravenous injection of dexamethasone (5mg) five minutes prior to anesthesia induction to prevent postoperative nausea and vomiting in both groups. The following data were collected: duration of operation, pneumoperitoneum time, extubation time, respiratory recovery time; Incidence of postoperative nausea and vomiting at different time intervals: Postanesthesia care unit residence period (T1), 0-3h after extubation (T2), 3-6h after extubation (T3), 6-12h after extubation (T4), 12-24h after extubation (T5); Visual analogue pain score : Postanesthesia care unit residence period (T1), 0-3h after extubation (T2), 3-6h after extubation (T3), 6-12h after extubation (T4), 12-24h after extubation (T5); Frequency of use of analgesics and antiemetic drugs; Incidence of adverse reactions within 24 hours after surgery; Postoperative satisfaction.

Conditions

• Motion Sickness
• Postoperative Nausea and Vomiting
• Ibuprofen

Interventions

Type	Name	Description
DRUG	Ibuprofen	0.8g intravenous injection 30min before the end of the operation
DRUG	sufentanil	0.2ug/kg intravenous injection 30min before the end of the operation

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2024-01-31
• Last updated: 2024-01-31

Locations

1 site across 1 country: China