A Phase 4 interventional study of Ibuprofen and sufentanil in Motion Sickness, Postoperative Nausea and Vomiting and Ibuprofen, sponsored by Second Hospital of Jilin University. Completed at 1 site in China. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Second Hospital of Jilin University · Phase 4, Interventional, and Prevention
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:
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.
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.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 66 is above the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Second Hospital of Jilin University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 0.8g ibuprofen intravenously 30 minutes before the end of the procedure
Drug: Ibuprofen
Participants received 0.2ug/kg of sufentanil intravenously 30 minutes before the end of the procedure
Drug: sufentanil
0.8g intravenous injection 30min before the end of the operation
0.2ug/kg intravenous injection 30min before the end of the operation
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
Time frame: 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
Time frame: 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
Time frame: From the end of surgery until 24 hours after surgery
Extubation time
the time from cessation of propofol and remifentanil infusion at the end of surgery to withdrawal of tracheal catheter
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the end of surgery until 24 hours after surgery
Time of pneumoperitoneum
Intraoperative condition
Time frame: From the beginning to the end of the surgery
Time of operation
Intraoperative condition
Time frame: From the beginning to the end of the surgery
Volume of fluids and blood loss
Intraoperative condition
Time frame: From the beginning to the end of the surgery
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibuprofen
Second Hospital of Jilin University