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CompletedNCT05748665Updated Mar 13, 2024

Effect of Remimazolam on the Recovery Quality After Day Surgery

An interventional study of Remimazolam besylate and etomidate in Elderly Patients and Ambulatory Surgery, sponsored by Xijing Hospital. Completed at 3 sites in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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.
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Conditions studied

  • Elderly Patients
  • Ambulatory Surgery
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In context

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    remimazolam

    remimazolam induction

    Drug: Remimazolam besylate

  • Active comparator
    etomidate

    etomidate induction

    Drug: etomidate

Interventions

  • DrugRemimazolam besylate

    Using remimazolam for induction of general anesthesia

  • Drugetomidate

    Using etomidate for induction of general anesthesia

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: postoperative day 1

Secondary outcomes

  1. The time of loss of consciousness

    The time of disappearance of the eyelash reflex within 3 minutes after the end of the intravenous anesthetic

    Time frame: within 3 minutes after the end of the intravenous anesthetic

  2. Adverse events

    Respiratory, cardiovascular and neurological system adverse events

    Time frame: During stay of post anesthesia care unit (up to 30minutes)

  3. the mean blood pressure,the systolic blood pressure ,the diastolic pressure

    Vital signs at different time points

    Time frame: From 5 minutes before anesthesia induction to the time point surgery start

  4. heart rate

    heart rate at different time points

    Time frame: From 5 minutes before anesthesia induction to the time point surgery start

  5. pulse oxygen saturation

    pulse oxygen saturation at different time points

    Time frame: From 5 minutes before anesthesia induction to the time point surgery start

07

Study locations

3 sites
  • The Fourth military medical university, Xijing Hospital
    Xi'an, Shannxi 710032, China
  • Xi 'an International Medical Center Hospital
    Xi'an, Shannxi 710119, China
  • Yan 'an University Affiliated Hospital
    Yanan, Shannxi 716200, China
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References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 29, 2022
  • Informed consent form · Nov 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05748665
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Mar 1, 2023
Start date
Aug 14, 2023
Primary completion
Jan 24, 2024
Completion
Jan 26, 2024
Last update
Mar 13, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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