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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting; Motion Sickness; Ibuprofen
• Intervention / Treatment: Drug: Ibuprofen; Drug: sufentanil

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen Group; Participants received 0.8g ibuprofen intravenously 30 minutes before the end of the procedure	Drug: Ibuprofen; 0.8g intravenous injection 30min before the end of the operation
Placebo Comparator: Sufentanil Group; Participants received 0.2ug/kg of sufentanil intravenously 30 minutes before the end of the procedure	Drug: sufentanil; 0.2ug/kg intravenous injection 30min before the end of the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Time of pneumoperitoneum	Intraoperative condition	From the beginning to the end of the surgery
Time of operation	Intraoperative condition	From the beginning to the end of the surgery
Volume of fluids and blood loss	Intraoperative condition	From the beginning to the end of the surgery

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University
• Investigators: Principal Investigator: dan Tian, 15526852169

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Motion Sickness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ibuprofen; Sufentanil
• Other Study ID Numbers: 2021/018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No