Postoperative Pain, AcuteNCT06260046
Effect of Sufentanil on the Postoperative Pain
A study testing Sufentanil and Remifentanil in people with Postoperative Pain, Acute, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Sufentanil and Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2024to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo elective robot-assisted nephrectomy surgery
- American Society of Anesthesiologists grade 1,2,3
- Age > 18 years old
Who cannot join
- Refuse to participate to the study
- Allergic history of opioid
- chronic pain
- opioid user before surgery
- MAO inhibitor user
- Severe respiratory insufficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam
Chang-Hoon Koo, vollock9@gmail.com
About this study
Official title: Analgesic Effect of Intraoperative Sufentanil on Postoperative Pain in Patients Undergoing Robot-assisted Nephrectomy: a Prospective Randomized Controlled Trial
This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Sufentanil, Remifentanil
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml
RemifentanilDrug
Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| sufentanil group | Experimental | sufentanil is administered for analgesic during general anesthesia Receives: Drug: Sufentanil |
| remifentanil group | Active comparator | remifentanil is administered for analgesic during general anesthesia Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
Measured: During post-anesthesia care unit(PACU) stay, until 1 hour
Secondary outcomes (4)
Richmond Agitation-Sedation scale
(+4), Combative, Overtly combative or violent; immediate danger to staff (+3), Very agitated, Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff (+2), Agitated, Frequent nonpurposeful movement or patient-ventilator dyssynchrony (+1), Restless, Anxious or apprehensive but movements not aggressive or vigorous 0, Alert and calm, Spontaneously pays attention to caregiver (-1), Drowsy, Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice (-2), Light sedation, Briefly (less than 10 seconds) awakens with eye contact to voice (-3), Moderate sedation, Any movement (but no eye contact) to voice (-4), Deep sedation, No response to voice, but any movement to physical stimulation (-5), Unarousable, No response to voice or physical stimulation
Measured: During post-anesthesia care unit(PACU) stay, until 1 hour
Incidence of postoperative nausea and vomiting
Measured: During post-anesthesia care unit(PACU) stay, until 1 hour
Number of patients who administered antiemetics
ramosetron will be administered as antiemetics
Measured: During post-anesthesia care unit(PACU) stay, until 1 hour
Pain score
Numeric rating scale (0=none, 10=extremely pain)
Measured: immediately after surgery, 15minutes, 30minutes, 60minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Koo, Seoul National University Hospital
- Investigators
- Chang-Hoon Koo, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260046
- Sponsor's protocol ID
- Robot Nx-SFTN
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Intraoperative Sufentanil on Postoperative Pain in Patients Undergoing Robot-assisted Nephrectomy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06260046
- Acronym / sponsor ID
- Robot Nx-SFTN
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 15 Feb 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.
This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sufentanil group | Experimental | Drug: Sufentanilsufentanil is administered for analgesic during general anesthesia |
| remifentanil group | Active comparator | Drug: Remifentanilremifentanil is administered for analgesic during general anesthesia |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who undergo elective robot-assisted nephrectomy surgery
- American Society of Anesthesiologists grade 1,2,3
- Age > 18 years old
Key exclusion criteria (6 listed)
- Refuse to participate to the study
- Allergic history of opioid
- chronic pain
- opioid user before surgery
- MAO inhibitor user
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 |
|---|---|---|
| SufentanilInduction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml | Drug | sufentanil group |
| RemifentanilInduction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml | Drug | remifentanil group |
Primary outcome
opioid consumption
Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour
4 secondary outcomes
Richmond Agitation-Sedation scale
Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour
Incidence of postoperative nausea and vomiting
Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour
Number of patients who administered antiemetics
Time frame: During post-anesthesia care unit(PACU) stay, until 1 hour
Pain score
Time frame: immediately after surgery, 15minutes, 30minutes, 60minutes after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Chang-Hoon Koo principal investigator
Seoul National University Bundang Hospital
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 and Remifentanil in people with Postoperative Pain, Acute, run by Seoul National University Hospital 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 6 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: opening soon, as of the sponsor's last update on 15 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Koo (+821085098841, vollock9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption (time frame: During post-anesthesia care unit(PACU) stay, until 1 hour). 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 15 Feb 2024.