Effect of Remimazolam on the Recovery Quality After Day Surgery

Elderly Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748665
• Other study ID #: KY20222277-F-1
• Status: Completed
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: January 26, 2024

Study information

• Verified date: January 2024
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 26, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Surgery
• Elderly Patients

Intervention

Drug:
• Remimazolam besylate
Using remimazolam for induction of general anesthesia
• etomidate
Using etomidate for induction of general anesthesia

Locations

Country	Name	City	State
China	The Fourth military medical university, Xijing Hospital	Xi'an	Shannxi
China	Xi 'an International Medical Center Hospital	Xi'an	Shannxi
China	Yan 'an University Affiliated Hospital	Yanan	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	postoperative day 1
Secondary	The time of loss of consciousness	The time of disappearance of the eyelash reflex within 3 minutes after the end of the intravenous anesthetic	within 3 minutes after the end of the intravenous anesthetic
Secondary	Adverse events	Respiratory, cardiovascular and neurological system adverse events	During stay of post anesthesia care unit (up to 30minutes)
Secondary	the mean blood pressure,the systolic blood pressure ,the diastolic pressure	Vital signs at different time points	From 5 minutes before anesthesia induction to the time point surgery start
Secondary	heart rate	heart rate at different time points	From 5 minutes before anesthesia induction to the time point surgery start
Secondary	pulse oxygen saturation	pulse oxygen saturation at different time points	From 5 minutes before anesthesia induction to the time point surgery start