Stomach NeoplasmsNCT05785234
The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain
A study testing sufentanil-remimazolam group and remifentanil-remimazolam group in people with Stomach Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial summary
In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- sufentanil-remimazolam group and remifentanil-remimazolam group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2023to Jun 2025
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20years or older
- Scheduled for laparoscopic-assisted gastrectomy
- American Society of Anesthesiologists(ASA) physical status I and III
Who cannot join
- Emergency operation
- Patients with a history of severe hypersensitivity reaction to dextran 40
- Patients who cannot use patient controlled analgesia(PCA)
- Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
- Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
- Patients with history of heart failure (unstable angina, congestive heart failure)
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- Patients with history of liver failure, renal failure, allergic to medicine
- Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia)
- Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
- Patients with obstructive sleep apnea
- Patients who cannot read the consent form (examples: Illiterate, foreigner)
- Patients who withdraw the consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul
Sun Joon Bai, 82-2-2228-4438, SJBAE@yuhs.ac
About this study
Official title: The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-
In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.
- Conditions
- Stomach Neoplasms
- Being tested
- sufentanil-remimazolam group, remifentanil-remimazolam group
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanil-remimazolam groupDrug
Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 0.5 ng·ml-1 of sufentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 0.2 - 0.6 ng·ml-1 of sufentanil.
remifentanil-remimazolam groupDrug
Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 4 ng·ml-1 of remifentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 2-6 ng·ml-1 of remifentanil.
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil-remimazolam group | Experimental | The sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam. Receives: Drug: sufentanil-remimazolam group |
| Remifentanil-remimazolam group | Active comparator | The remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam. Receives: Drug: remifentanil-remimazolam group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of fentanyl in 24 hours after surgery
To investigate the effect of total intravenous anesthesia with intraoperative sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain, total cumulative dose of fentanyl was measured for the first postoperative 24 hour.
Measured: after 24 hours postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Joon Bai, MD, PhD, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785234
- Sponsor's protocol ID
- 4-2022-1606
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-
- ClinicalTrials.gov ID
- NCT05785234
- Acronym / sponsor ID
- 4-2022-1606
- Conditions
- Stomach Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Mar 2023 (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.
In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil-remimazolam group | Experimental | Drug: sufentanil-remimazolam groupThe sufentanil-remimazolam group receives total intravenous anesthesia with sufentanil-remimazolam. |
| Remifentanil-remimazolam group | Active comparator | Drug: remifentanil-remimazolam groupThe remifentanil-remimazolam group receives total intravenous anesthesia with remifentanil-remimazolam. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20years or older
- Scheduled for laparoscopic-assisted gastrectomy
- American Society of Anesthesiologists(ASA) physical status I and III
Key exclusion criteria (12 listed)
- Emergency operation
- Patients with a history of severe hypersensitivity reaction to dextran 40
- Patients who cannot use patient controlled analgesia(PCA)
- Patients with morbid obesity [body mass index (BMI) >35 kg/m2]
- Patients with history of uncontrolled hypertension (diastolic BP >110mmHg) or DM
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 |
|---|---|---|
| sufentanil-remimazolam groupInduction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 0.5 ng·ml-1 of sufentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 0.2 - 0.6 ng·ml-1 of sufentanil. | Drug | Sufentanil-remimazolam group |
| remifentanil-remimazolam groupInduction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 4 ng·ml-1 of remifentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 2-6 ng·ml-1 of remifentanil. | Drug | Remifentanil-remimazolam group |
Primary outcome
Total consumption of fentanyl in 24 hours after surgery
Time frame: after 24 hours postoperative period
To investigate the effect of total intravenous anesthesia with intraoperative sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain, total cumulative dose of fentanyl was measured for the first postoperative 24 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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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.
Sun Joon Bai, MD, PhD principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sufentanil-remimazolam group and remifentanil-remimazolam group in people with Stomach Neoplasms, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Mar 2023. 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Joon Bai, MD, PhD (82-2-2228-4438, SJBAE@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total consumption of fentanyl in 24 hours after surgery (time frame: after 24 hours postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023.