Day SurgeryNCT05320016
Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery
An observational study of Day Surgery and Patient Outcome Assessment, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse… Read more about this study
- Who is it for?
- Ages 19 to 75 years, women only
- Conditions the study is for
- Day Surgery, Patient Outcome Assessment, Quality of Recovery
- What is being tested?
- Remimazolam
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2021to 31 Dec 2021
- Phase
- Observational
- 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 to 75 years
- Women only
- Adult, Older adult
Study population: Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
Who may be able to join
- Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
- American Society of Anesthesiology grade 1 or 2
Who cannot join
- Underlying diseases: liver, kidney, brain nervous system, glaucoma
- Patients with BMI greater than 30 and less than 18.5
- Patients diagnosed with sleep apnea
- Alcohol or drug dependent patients
- Patients with severe or acute respiratory failure
- Lactose intolerance
- Dextran 40 hypersensitivity
- Patients in shock or coma
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyunggi-do, 13620
About this study
Official title: Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study
Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.
Read the detailed description
To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.
- Being tested
- Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)
Effects of remimazolam on quality of recovery scores after ambulatory hysteroscopic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)
Measured: 24 hours after ambulatory hysteroscopic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Nov 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Day SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sang-Hwan Do, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320016
- Sponsor's protocol ID
- B-2109-708-309
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05320016
- Acronym / sponsor ID
- B-2109-708-309
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Apr 2022 (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.
Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.
Detailed description
To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
Key inclusion criteria (2 listed)
- Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
- American Society of Anesthesiology grade 1 or 2
Key exclusion criteria (8 listed)
- Underlying diseases: liver, kidney, brain nervous system, glaucoma
- Patients with BMI greater than 30 and less than 18.5
- Patients diagnosed with sleep apnea
- Alcohol or drug dependent patients
- Patients with severe or acute respiratory failure
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 |
|---|---|---|
| RemimazolamAlso: the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)Effects of remimazolam on quality of recovery scores after ambulatory hysteroscopic surgery | Drug | – |
Primary outcome
Quality of recovery
Time frame: 24 hours after ambulatory hysteroscopic surgery
the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)
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 11 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Day Surgery
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Active, not recruiting
BIA-Guided vs. Conventional Fluid Resuscitation in ICU Patients
Fluid and Electrolyte Imbalance, Anesthesia
RecruitingPhase 1
Impact of Early ADL Education on Outcomes Post DRF ORIF
Distal Radius Fractures
Recruiting
Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
Ovary Cancer, Endometrial Cancer
RecruitingPhase 2/3
Autologous Cold-stored Apheresis Platelets
Bleeding, Platelets
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.
Sang-Hwan Do 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?
An observational study of Day Surgery and Patient Outcome Assessment, 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 2 inclusion and 8 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 11 Apr 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?
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?
Quality of recovery (time frame: 24 hours after ambulatory hysteroscopic surgery). 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 11 Apr 2022.