Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06232785
• Other study ID #: 2021/018
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Second Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 18-60 years old;

2. Class I - II patients according to the American Society of Anesthesiologists classification;

3. Body mass index : 20-27kg/?;

4. non-life-threatening diseases of heart, lung, brain, liver, kidney and other important organs;

5. No recent use of sedatives, opioids, non-steroidal drugs such as ibuprofen, antiemetic drugs.

6. No history of digestive tract ulcer;

7. Motion sickness patients undergoing gynecological endoscopic surgery under general anesthesia.

8. Postoperative analgesia pump is not required.

Exclusion Criteria:

1. Low weight, poor general state;

2. general anesthesia drug allergy;

3. Long-term use of painkillers, antiemetic drugs, or use of opioids within 12 hours before surgery.

Related Conditions & MeSH terms

• Ibuprofen
• Motion Sickness
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Ibuprofen
0.8g intravenous injection 30min before the end of the operation
• sufentanil
0.2ug/kg intravenous injection 30min before the end of the operation

Locations

Country	Name	City	State
China	Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of postoperative nausea and vomiting between the two groups	Incidence of postoperative nausea and vomiting at different time intervals: Pstanesthesia 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); postoperative nausea and vomiting grading 24h after surgery: According to the severity of postoperative nausea and vomiting, postoperative nausea and vomiting was divided into 1-4 grades. Grade I: no nausea or vomiting; Grade II: mild nausea, abdominal discomfort, but no vomiting; Grade III: obvious vomiting, but no contents of the vomit; Grade IV: Severe vomiting with gastric juices and other contents. Postoperatively PONV is considered to occur in patients with grade II or higher	From the end of surgery until 24 hours after surgery
Primary	Visual Analogue Score scores in postoperative resting state of patients in two groups	Visual analogue pain score : Pstanesthesia 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); Pain score 24h after operation: Pain Assessment Scale was used to evaluate the analgesic effect of the two groups. 0 doesn't hurt; 1 to 3 points - mild pain; 4 to 6 points - moderate pain; Score 7-10 - severe pain	From the end of surgery until 24 hours after surgery
Primary	Comparison of vomiting between the two groups	Postoperative vomiting score 24 hours after surgery: Postoperative vomiting was divided into 0-3 points according to the degree of vomiting. 0 score: no vomiting; 1 point: vomiting 1-2 times; 2 points: vomiting 3 to 5 times; 3 marks: vomiting > 5 times	From the end of surgery until 24 hours after surgery
Secondary	Extubation time	the time from cessation of propofol and remifentanil infusion at the end of surgery to withdrawal of tracheal catheter	One minute after surgery
Secondary	Respiratory recovery time	the time from the end of surgery when propofol and remifentanil infusion were stopped to the time when patients resumed breathing on their own	One minute after surgery
Secondary	Occurrence of adverse reactions	The incidence of postoperative adverse reactions such as dizziness, headache, agitation, respiratory depression and skin pruritus were compared between the two groups	Within 24 hours of extubation
Secondary	Score of patient satisfaction	Patient satisfaction score: 0: very satisfied, 1: average, 2: unsatisfactory. A score of more than 1 is considered poor satisfaction	From the end of surgery until 24 hours after surgery
Secondary	Time of pneumoperitoneum	Intraoperative condition	From the beginning to the end of the surgery
Secondary	Time of operation	Intraoperative condition	From the beginning to the end of the surgery
Secondary	Volume of fluids and blood loss	Intraoperative condition	From the beginning to the end of the surgery