Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

NCT06232785 | Completed Phase 4

• 1 other identifier: 2021/018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness; Postoperative Nausea and Vomiting; Ibuprofen

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Extubation time

  One minute after surgery

• Respiratory recovery time

  One minute after surgery

• Occurrence of adverse reactions

  Within 24 hours of extubation

• Score of patient satisfaction

  From the end of surgery until 24 hours after surgery

• Time of pneumoperitoneum

  From the beginning to the end of the surgery

Study Arms (2)

Ibuprofen Group

EXPERIMENTAL

Participants received 0.8g ibuprofen intravenously 30 minutes before the end of the procedure

Drug: Ibuprofen

Sufentanil Group

PLACEBO COMPARATOR

Participants received 0.2ug/kg of sufentanil intravenously 30 minutes before the end of the procedure

Drug: sufentanil

Interventions

Ibuprofen DRUG

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

Ibuprofen Group

sufentanil DRUG

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

Sufentanil Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Jilin University: lead

Study Sites (1)

Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Motion Sickness; Postoperative Nausea and Vomiting

Interventions

Ibuprofen; Sufentanil

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• dan Tian

  15526852169

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 31, 2024
• Study Start: February 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)