Motion SicknessPhase 4NCT06232785

Gynecologic Endoscopic Surgery of Female Motion Sickness Patients

A Phase 4 study testing Ibuprofen and sufentanil in people with Motion Sickness and Postoperative Nausea and Vomiting, run by Second Hospital of Jilin University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Motion Sickness, Postoperative Nausea and Vomiting, Ibuprofen
What is being tested?: Ibuprofen and sufentanil
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteChina
Study dates: 1 Feb 2022to 1 Dec 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Second Hospital of Jilin University
Changchun, Jilin, 130000

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Motion Sickness, Postoperative Nausea and Vomiting, Ibuprofen
Being tested: Ibuprofen, sufentanil
Medical subject headings: Motion Sickness, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IbuprofenDrug
0.8g intravenous injection 30min before the end of the operation
sufentanilDrug
0.2ug/kg intravenous injection 30min before the end of the operation

Study groups in NCT06232785
Study group	Role	What they receive
Ibuprofen Group	Experimental	Participants received 0.8g ibuprofen intravenously 30 minutes before the end of the procedure Receives: Drug: Ibuprofen
Sufentanil Group	Placebo comparator	Participants received 0.2ug/kg of sufentanil intravenously 30 minutes before the end of the procedure Receives: Drug: sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: From the end of surgery until 24 hours after surgery

Secondary outcomes (7)

Extubation time
the time from cessation of propofol and remifentanil infusion at the end of surgery to withdrawal of tracheal catheter
Measured: 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
Measured: 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
Measured: 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
Measured: From the end of surgery until 24 hours after surgery
Time of pneumoperitoneum
Intraoperative condition
Measured: From the beginning to the end of the surgery
Time of operation
Intraoperative condition
Measured: From the beginning to the end of the surgery
Volume of fluids and blood loss
Intraoperative condition
Measured: From the beginning to the end of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20221 Dec 2023

First posted31 Jan 2024
Study start1 Feb 2022
Primary completion1 Oct 2023
Study completion1 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Motion SicknessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06232785
Sponsor's protocol ID: 2021/018
Status last verified: Jan 2024
First submitted: 7 Jan 2024
Last updated: 31 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Vagal Auricular Stimulation for Motion Sickness
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StableEyes With Active Neurofeedback
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All Motion Sickness trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Remifentanil Target Controlled Infusion Combined With Ibuprofen Injection in Gynecologic Endoscopic Surgery of Female Motion Sickness Patients
ClinicalTrials.gov ID: NCT06232785
Acronym / sponsor ID: 2021/018
Conditions: Motion Sickness, Postoperative Nausea and Vomiting, Ibuprofen
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Second Hospital of Jilin UniversityUniversity, hospital or other
Study start: 1 Feb 2022 (actual)
Primary completion: 1 Oct 2023 (actual)
Study completion: 1 Dec 2023 (actual)
First posted: 31 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ibuprofen Group	Experimental	Drug: IbuprofenParticipants received 0.8g ibuprofen intravenously 30 minutes before the end of the procedure
Sufentanil Group	Placebo comparator	Drug: sufentanilParticipants received 0.2ug/kg of sufentanil intravenously 30 minutes before the end of the procedure

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ibuprofen0.8g intravenous injection 30min before the end of the operation	Drug	Ibuprofen Group
sufentanil0.2ug/kg intravenous injection 30min before the end of the operation	Drug	Sufentanil Group

Primary outcome

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
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
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

7 secondary outcomes

Extubation time
Time frame: One minute after surgery
Respiratory recovery time
Time frame: One minute after surgery
Occurrence of adverse reactions
Time frame: Within 24 hours of extubation
Score of patient satisfaction
Time frame: From the end of surgery until 24 hours after surgery
Time of pneumoperitoneum
Time frame: From the beginning to the end of the surgery
Time of operation
Time frame: From the beginning to the end of the surgery
Volume of fluids and blood loss
Time frame: From the beginning to the end of the surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.

Related trials for Motion Sickness

Enrolling by invitationObservational study
Virtual Reality Sickness Questionnaire: Psychometrics in Stroke Patients
Motion Sickness
Not yet recruiting
Vagal Auricular Stimulation for Motion Sickness
Chronic Nausea
Recruiting
StableEyes With Active Neurofeedback
Vestibular Disorder, Vestibular Schwannoma
Not yet recruitingObservational study
Motion Sickness Severity and Sensorimotor Performance
Motion Sickness, Somatosensory Disorders
Not yet recruiting
OKT With Gaze and Postural Stabilization on Vertigo, MS and QOL in VBH
Vestibular Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

dan Tian principal investigator

15526852169

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibuprofen and sufentanil in people with Motion Sickness and Postoperative Nausea and Vomiting, run by Second Hospital of Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of postoperative nausea and vomiting between the two groups (time frame: From the end of surgery until 24 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06232785.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.