Elderly PatientsNCT05748665
Effect of Remimazolam on the Recovery Quality After Day Surgery
A study testing Remimazolam besylate and etomidate in people with Elderly Patients and Ambulatory Surgery, run by Xijing Hospital at 3 sites in China.
Trial summary
The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Patients, Ambulatory Surgery
- What is being tested?
- Remimazolam besylate and etomidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesChina
- Study dates
- 14 Aug 2023to 26 Jan 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing day surgery under laryngeal mask anesthesia
- American society of anesthesiologists (ASA) grade 1-3
- BMI<30kg/m2
Who cannot join
- have benzodiazepines drugs in the latest month cognitive dysfunction
- Cognitive dysfunction and neuropsychiatric disorders
- It was estimated as a difficult airway
- There was a history of adrenal insufficiency, porphyria, or chronic corticosteroid therapy
- There is a contraindication or allergy to benzodiazepines, opioids, etomidate and its components
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Fourth military medical university, Xijing Hospital
Xi'an, Shannxi, 710032
Xi 'an International Medical Center Hospital
Xi'an, Shannxi, 710119
Yan 'an University Affiliated Hospital
Yanan, Shannxi, 716200
About this study
Official title: Effect of Remimazolam Induction on the Recovery Quality After Day Surgery in Elderly Patients: a Comparison Study With Etomidate
The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. The main question it aims to answer is:
- The quality of postoperative recovery induced by remimazolam for laryngeal mask general anesthesia in elderly patients undergoing day surgery is not inferior to that induced by etomidate Participants will be given remimazolam to induce anesthesia。 Researchers will compare etomidate to see if the quality of postoperative recovery.
- Conditions
- Elderly Patients, Ambulatory Surgery
- Being tested
- Remimazolam besylate, etomidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
Using remimazolam for induction of general anesthesia
etomidateDrug
Using etomidate for induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| remimazolam | Experimental | remimazolam induction Receives: Drug: Remimazolam besylate |
| etomidate | Active comparator | etomidate induction Receives: Drug: etomidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of recovery 15
The main goal of this study was to assess the QoR using the QoR-15 questionnaire, which is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).
Measured: postoperative day 1
Secondary outcomes (5)
The time of loss of consciousness
The time of disappearance of the eyelash reflex within 3 minutes after the end of the intravenous anesthetic
Measured: within 3 minutes after the end of the intravenous anesthetic
Adverse events
Respiratory, cardiovascular and neurological system adverse events
Measured: During stay of post anesthesia care unit (up to 30minutes）
the mean blood pressure，the systolic blood pressure ，the diastolic pressure
Vital signs at different time points
Measured: From 5 minutes before anesthesia induction to the time point surgery start
heart rate
heart rate at different time points
Measured: From 5 minutes before anesthesia induction to the time point surgery start
pulse oxygen saturation
pulse oxygen saturation at different time points
Measured: From 5 minutes before anesthesia induction to the time point surgery start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start14 Aug 2023
- Primary completion24 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748665
- Sponsor's protocol ID
- KY20222277-F-1
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remimazolam Induction on the Recovery Quality After Day Surgery in Elderly Patients: a Comparison Study With Etomidate
- ClinicalTrials.gov ID
- NCT05748665
- Acronym / sponsor ID
- KY20222277-F-1
- Conditions
- Elderly Patients, Ambulatory Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 1 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.
The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. The main question it aims to answer is:
- The quality of postoperative recovery induced by remimazolam for laryngeal mask general anesthesia in elderly patients undergoing day surgery is not inferior to that induced by etomidate Participants will be given remimazolam to induce anesthesia。 Researchers will compare etomidate to see if the quality of postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remimazolam | Experimental | Drug: Remimazolam besylateremimazolam induction |
| etomidate | Active comparator | Drug: etomidateetomidate induction |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing day surgery under laryngeal mask anesthesia
- American society of anesthesiologists (ASA) grade 1-3
- BMI<30kg/m2
Key exclusion criteria (5 listed)
- have benzodiazepines drugs in the latest month cognitive dysfunction
- Cognitive dysfunction and neuropsychiatric disorders
- It was estimated as a difficult airway
- There was a history of adrenal insufficiency, porphyria, or chronic corticosteroid therapy
- There is a contraindication or allergy to benzodiazepines, opioids, etomidate and its components
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 |
|---|---|---|
| Remimazolam besylateUsing remimazolam for induction of general anesthesia | Drug | remimazolam |
| etomidateUsing etomidate for induction of general anesthesia | Drug | etomidate |
Primary outcome
The quality of recovery 15
Time frame: postoperative day 1
The main goal of this study was to assess the QoR using the QoR-15 questionnaire, which is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).
5 secondary outcomes
The time of loss of consciousness
Time frame: within 3 minutes after the end of the intravenous anesthetic
Adverse events
Time frame: During stay of post anesthesia care unit (up to 30minutes）
the mean blood pressure，the systolic blood pressure ，the diastolic pressure
Time frame: From 5 minutes before anesthesia induction to the time point surgery start
heart rate
Time frame: From 5 minutes before anesthesia induction to the time point surgery start
pulse oxygen saturation
Time frame: From 5 minutes before anesthesia induction to the time point surgery start
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 13 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam besylate and etomidate in people with Elderly Patients and Ambulatory Surgery, run by Xijing Hospital at 3 sites in China.
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 5 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 15 (time frame: postoperative day 1). 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 13 Mar 2024.