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NCT Number: NCT06232785

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Second Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-60 years old;
  • Class I - II patients according to the American Society of Anesthesiologists classification;
  • Body mass index : 20-27kg/㎡;
  • non-life-threatening diseases of heart, lung, brain, liver, kidney and other important organs;
  • No recent use of sedatives, opioids, non-steroidal drugs such as ibuprofen, antiemetic drugs.
  • No history of digestive tract ulcer;
  • Motion sickness patients undergoing gynecological endoscopic surgery under general anesthesia.
  • Postoperative analgesia pump is not required.

Exclusion criteria

  • Low weight, poor general state;
  • general anesthesia drug allergy;
  • Long-term use of painkillers, antiemetic drugs, or use of opioids within 12 hours before surgery.

Treatment and study plan

Ibuprofen

Drug

0.8g intravenous injection 30min before the end of the operation

Sufentanil

Drug

0.2ug/kg intravenous injection 30min before the end of the operation

Primary outcomes

  1. Comparison of postoperative nausea and vomiting between the two groups

    Time frame: From the end of surgery until 24 hours after surgery

    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

  2. Visual Analogue Score scores in postoperative resting state of patients in two groups

    Time frame: From the end of surgery until 24 hours after surgery

    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

  3. Comparison of vomiting between the two groups

    Time frame: From the end of surgery until 24 hours after surgery

    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

Secondary outcomes

  1. Extubation time

    Time frame: One minute after surgery

    the time from cessation of propofol and remifentanil infusion at the end of surgery to withdrawal of tracheal catheter

  2. Respiratory recovery time

    Time frame: One minute after surgery

    the time from the end of surgery when propofol and remifentanil infusion were stopped to the time when patients resumed breathing on their own

  3. Occurrence of adverse reactions

    Time frame: Within 24 hours of extubation

    The incidence of postoperative adverse reactions such as dizziness, headache, agitation, respiratory depression and skin pruritus were compared between the two groups

  4. Score of patient satisfaction

    Time frame: From the end of surgery until 24 hours after surgery

    Patient satisfaction score: 0: very satisfied, 1: average, 2: unsatisfactory. A score of more than 1 is considered poor satisfaction

  5. Time of pneumoperitoneum

    Time frame: From the beginning to the end of the surgery

    Intraoperative condition

  6. Time of operation

    Time frame: From the beginning to the end of the surgery

    Intraoperative condition

  7. Volume of fluids and blood loss

    Time frame: From the beginning to the end of the surgery

    Intraoperative condition

Sponsors and collaborators

Lead sponsor

Second Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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