Gynecologic DiseaseNCT04409964
the Effect of Opioid-free General Anesthesia
A study testing Dexmedetomidine Hydrochloride, Lidocaine Hydrochloride and Remifentanil Hydrochloride in people with Gynecologic Disease, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Dexmedetomidine Hydrochloride, Lidocaine Hydrochloride and Remifentanil Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jun 2020to 20 Sep 2021
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for gynecological laparoscopic surgery
Who cannot join
- refusal to participate in this study
- emergent surgery
- chronic pain requiring for pain killer
- psychiatric disease
- preoperative bradycardia or hypotension
- allergy or history of the adverse effect to study drug
- pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 06591
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 07651
About this study
Official title: the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy
This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.
Read the detailed description
The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.
- Conditions
- Gynecologic Disease
- Being tested
- Dexmedetomidine Hydrochloride, Lidocaine Hydrochloride, Remifentanil Hydrochloride
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called precedex
dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia
Lidocaine HydrochlorideDrug
Also called lidocaine
lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia
Remifentanil HydrochlorideDrug
Also called remifentanil
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| opioid-free anesthesia | Experimental | The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy. Receives: Drug: Dexmedetomidine Hydrochloride; Drug: Lidocaine Hydrochloride |
| opioid anesthesia | Active comparator | The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy. Receives: Drug: Remifentanil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of recovery
The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.
Measured: at 24 hour after the completion of surgery
Secondary outcomes (1)
cytokine
as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Youngeun Moon, MD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409964
- Sponsor's protocol ID
- OFGA
- Status last verified
- Feb 2022
- First submitted
- 26 May 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song JY, Choi H, Chae M, Ko J, Moon YE. The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial. Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.
PubMed 33712080
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT04409964
- Acronym / sponsor ID
- OFGA
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 1 Jun 2020 (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 performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.
Detailed description
The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid-free anesthesia | Experimental | Drug: Dexmedetomidine Hydrochloride, Drug: Lidocaine HydrochlorideThe study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy. |
| opioid anesthesia | Active comparator | Drug: Remifentanil HydrochlorideThe control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient scheduled for gynecological laparoscopic surgery
Key exclusion criteria (7 listed)
- refusal to participate in this study
- emergent surgery
- chronic pain requiring for pain killer
- psychiatric disease
- preoperative bradycardia or hypotension
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 |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: precedexdexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia | Drug | opioid-free anesthesia |
| Lidocaine HydrochlorideAlso: lidocainelidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia | Drug | opioid-free anesthesia |
| Remifentanil HydrochlorideAlso: remifentanilremifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia | Drug | opioid anesthesia |
Primary outcome
the quality of recovery
Time frame: at 24 hour after the completion of surgery
The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.
1 secondary outcome
cytokine
Time frame: during 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 22 Feb 2022.
- Derived from this study: PubMed 33712080Song JY, Choi H, Chae M, Ko J, Moon YE. The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial. Trials. 2021 Mar 12;22(1):207. doi: 10.1186/s13063-021-05166-z.
- 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. This study is not recruiting at the moment.
Youngeun Moon, MD principal investigator
Seoul St. Mary's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Hydrochloride, Lidocaine Hydrochloride and Remifentanil Hydrochloride in people with Gynecologic Disease, run by The Catholic University of Korea at 2 sites 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 1 inclusion and 7 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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
the quality of recovery (time frame: at 24 hour after the completion of surgery). 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 NCT04409964, which also lists 1 linked publication.
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 22 Feb 2022.