Gynecologic DiseaseNCT04700761
Opioid-free Anesthesia in Gynecologic Surgery
A study testing Opioid-free anesthesia and Opioid-using anesthesia in people with Gynecologic Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Opioid-free anesthesia and Opioid-using anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 30 Jul 2022
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease
- Age ≥ 19
- ASA (American Society of Anesthesiologists) class I-II
Who cannot join
- Uncontrolled hypertension
- Untreated intracranial aneurysm
- Severely impaired renal or hepatic function
- Pregnancy
- History of hypersensitivity for drugs used in the study
- Patients not using NSAID-containing IV PCA (patient controlled analgesia) device post-operatively
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Hyo-Seok Na, 1087012913, hsknana@gmail.com
About this study
Official title: Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery
Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.
- Conditions
- Gynecologic Disease
- Being tested
- Opioid-free anesthesia, Opioid-using anesthesia
- Keywords
- Analgesics, opioid, Postoperative nausea, Laparoscopy, Gynecologic surgical procedures
- Medical subject headings
- Genital Diseases, Female, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-free anesthesiaProcedure or surgery
Anesthesia induction: thiopental, rocuronium, desflurane + single dose of alfentanil for endotracheal intubation Anesthesia maintenance: desflurane (without any opioid) Rescue for hypertension, tachycardia: desflurane and beta blocker/calcium channel blocker
Opioid-using anesthesiaProcedure or surgery
Anesthesia induction: thiopental, rocuronium, desflurane + continuous infusion of remifentanil (TCI, Minto model) Anesthesia maintenance: desflurane, remifentanil Rescue for hypertension, tachycardia: desflurane, remifantanil and beta blocker/calcium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Group OFA (Opioid-free anesthesia) | Experimental | Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation) Receives: Procedure: Opioid-free anesthesia |
| Group OUA (Opioid-using anesthesia) | Active comparator | Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil) Receives: Procedure: Opioid-using anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total incidence of post-operative nausea
Y/N
Measured: up to post-operative day 2
Secondary outcomes (6)
Incidence of post-operative nausea
Y/N
Measured: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Severity of post-operative nausea
Grading: none, mild, moderate, severe
Measured: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Incidence of post-operative retching/vomiting
Y/N
Measured: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Rescue antiemetic agent use
Number of administration
Measured: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Post-operative pain score
Grading: 11-point numeric pain scale (0-10, 10 means the worst pain)
Measured: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Rescue pain medication use
Number of administration
Measured: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2021
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700761
- Sponsor's protocol ID
- B-2006-619-004
- Status last verified
- Jul 2022
- First submitted
- 19 Oct 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT04700761
- Acronym / sponsor ID
- B-2006-619-004
- Conditions
- Gynecologic Disease
- Keywords
- Analgesics, opioid, Postoperative nausea, Laparoscopy, Gynecologic surgical procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 8 Jan 2021 (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.
Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group OFA (Opioid-free anesthesia) | Experimental | Procedure: Opioid-free anesthesiaNot using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation) |
| Group OUA (Opioid-using anesthesia) | Active comparator | Procedure: Opioid-using anesthesiaUsing opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease
- Age ≥ 19
- ASA (American Society of Anesthesiologists) class I-II
Key exclusion criteria (6 listed)
- Uncontrolled hypertension
- Untreated intracranial aneurysm
- Severely impaired renal or hepatic function
- Pregnancy
- History of hypersensitivity for drugs used in the study
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 |
|---|---|---|
| Opioid-free anesthesiaAnesthesia induction: thiopental, rocuronium, desflurane + single dose of alfentanil for endotracheal intubation Anesthesia maintenance: desflurane (without any opioid) Rescue for hypertension, tachycardia: desflurane and beta blocker/calcium channel blocker | Procedure or surgery | Group OFA (Opioid-free anesthesia) |
| Opioid-using anesthesiaAnesthesia induction: thiopental, rocuronium, desflurane + continuous infusion of remifentanil (TCI, Minto model) Anesthesia maintenance: desflurane, remifentanil Rescue for hypertension, tachycardia: desflurane, remifantanil and beta blocker/calcium channel blocker | Procedure or surgery | Group OUA (Opioid-using anesthesia) |
Primary outcome
Total incidence of post-operative nausea
Time frame: up to post-operative day 2
Y/N
6 secondary outcomes
Incidence of post-operative nausea
Time frame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Severity of post-operative nausea
Time frame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Incidence of post-operative retching/vomiting
Time frame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Rescue antiemetic agent use
Time frame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Post-operative pain score
Time frame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Rescue pain medication use
Time frame: day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid-free anesthesia and Opioid-using anesthesia in people with Gynecologic Disease, run by Seoul National University Bundang 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 Hyo-Seok Na (+821087012913, hsknana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total incidence of post-operative nausea (time frame: up to post-operative day 2). 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 5 Jul 2022.