Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
2021/018
Description
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.
Trial arms
Trial start
2022-02-01
Estimated PCD
2023-10-01
Trial end
2023-12-01
Status
Completed
Phase
Early phase I
Treatment
Ibuprofen
0.8g intravenous injection 30min before the end of the operation
Arms:
Ibuprofen Group
sufentanil
0.2ug/kg intravenous injection 30min before the end of the operation
Arms:
Sufentanil Group
Size
66
Primary endpoint
Comparison of postoperative nausea and vomiting between the two groups
From the end of surgery until 24 hours after surgery
Visual Analogue Score scores in postoperative resting state of patients in two groups
From the end of surgery until 24 hours after surgery
Comparison of vomiting between the two groups
From the end of surgery until 24 hours after surgery
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2024-01-31

1 organization

2 products

3 indications

Organization
Second Hospital of Jilin University
Product
Ibuprofen
Indication
Motion Sickness
Indication
Postoperative Nausea and Vomiting
Indication
Ibuprofen
Product
sufentanil