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Effect of Remimazolam on the Recovery Quality After Day Surgery

Effect of Remimazolam Induction on the Recovery Quality After Day Surgery in Elderly Patients: a Comparison Study With Etomidate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05748665
Enrollment
118
Registered
2023-03-01
Start date
2023-08-14
Completion date
2024-01-26
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgery, Elderly Patients

Brief 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. 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.

Interventions

DRUGRemimazolam besylate

Using remimazolam for induction of general anesthesia

DRUGetomidate

Using etomidate for induction of general anesthesia

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* undergoing day surgery under laryngeal mask anesthesia * American society of anesthesiologists (ASA) grade 1-3 * BMI\<30kg/m2

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The quality of recovery 15postoperative day 1The 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).

Secondary

MeasureTime frameDescription
The time of loss of consciousnesswithin 3 minutes after the end of the intravenous anestheticThe time of disappearance of the eyelash reflex within 3 minutes after the end of the intravenous anesthetic
Adverse eventsDuring stay of post anesthesia care unit (up to 30minutes)Respiratory, cardiovascular and neurological system adverse events
the mean blood pressure,the systolic blood pressure ,the diastolic pressureFrom 5 minutes before anesthesia induction to the time point surgery startVital signs at different time points
heart rateFrom 5 minutes before anesthesia induction to the time point surgery startheart rate at different time points
pulse oxygen saturationFrom 5 minutes before anesthesia induction to the time point surgery startpulse oxygen saturation at different time points

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026