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Completed

NCT Number: NCT05748665

Effect of Remimazolam on the Recovery Quality After Day Surgery

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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Key information

Conditions

Elderly Patients Ambulatory Surgery

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth military medical university, Xijing Hospital, Xi'an, Shannxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam besylate

Drug

Using remimazolam for induction of general anesthesia

Etomidate

Drug

Using etomidate for induction of general anesthesia

Primary outcomes

  1. 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).

Secondary outcomes

  1. The time of loss of consciousness

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

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

  2. Adverse events

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

    Respiratory, cardiovascular and neurological system adverse events

  3. 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

    Vital signs at different time points

  4. heart rate

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

    heart rate at different time points

  5. pulse oxygen saturation

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

    pulse oxygen saturation at different time points

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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