Clinical trial NCT06232785: Gynecologic Endoscopic Surgery of Female Motion Sickness Patients
Official title: Application of Remifentanil Target Controlled Infusion Combined With Ibuprofen Injection in Gynecologic Endoscopic Surgery of Female Motion Sickness Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Motion Sickness
Postoperative Nausea and Vomiting
Ibuprofen
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of postoperative nausea and vomiting between the two groups
timeFrame: From the end of surgery until 24 hours after surgery
measure: Visual Analogue Score scores in postoperative resting state of patients in two groups
timeFrame: From the end of surgery until 24 hours after surgery
measure: Comparison of vomiting between the two groups
timeFrame: From the end of surgery until 24 hours after surgery
Secondary outcomes:
measure: Extubation time
timeFrame: One minute after surgery
measure: Respiratory recovery time
timeFrame: One minute after surgery
measure: Occurrence of adverse reactions
timeFrame: Within 24 hours of extubation
measure: Score of patient satisfaction
timeFrame: From the end of surgery until 24 hours after surgery
measure: Time of pneumoperitoneum
timeFrame: From the beginning to the end of the surgery
measure: Time of operation
timeFrame: From the beginning to the end of the surgery
measure: Volume of fluids and blood loss
timeFrame: From the beginning to the end of the surgery
Other outcomes:
Locations:
city: Changchun
country: China
facility: Second Hospital of Jilin University
state: Jilin
Study officials:
affiliation: 15526852169
name: dan Tian
role: PRINCIPAL_INVESTIGATOR
References: