Fiberbronchoscopy
Conditions
Interventions
Ciprofol Group:For induction: Administer a bolus intravenous injection of Remimazolam at 0.2 mg/kg (over 30 seconds) along with Remifentanil at 1 µg/kg.
For maintenance: Initiate a continuous intraven
Remimazolam Group:For induction: Administer a bolus intravenous injection of Ciprofol at 0.4 mg/kg (over 30 seconds) along with Remifentanil at 1 µg/kg.
For maintenance: Initiate a continuous intraven
Sponsors
People's Hospital of Ningxia Hui Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients scheduled for elective diagnostic or therapeutic fiberoptic bronchoscopy under general anesthesia were enrolled. The inclusion criteria were: age between 18 and 65 years, a Body Mass Index (BMI) ranging from 20 to 30 kg/m², an American Society of Anesthesiologists (ASA) physical status classification of II or III, and a baseline peripheral oxygen saturation (SpO2) greater than or equal to 90% while breathing room air.
Exclusion criteria
Exclusion criteria: Patients were excluded for any of the following reasons: known allergy to the study drugs or their adjuvants; history of substance or alcohol abuse; severe sleep apnea syndrome (Apnea-Hypopnea Index > 40); severe cardiopulmonary disease (e.g., uncontrolled heart failure, PaO2 < 60 mmHg, or SpO2 < 90% on room air); severe hepatic or renal dysfunction (Child-Pugh class C or estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73m²); anticipated difficult airway (Mallampati class IV); pregnancy or lactation; participation in any other clinical trial within the past 3 months; presence of severe psychiatric or mood disorders, or inability to complete the study interviews. Additionally, patients who required emergency endotracheal intubation during the procedure were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sedation success rate and the incidence of hypoxia (Sedation success was defined as the completion of the entire endoscopic procedure with no more than three supplemental doses of the study drug required after the initial dose. Hypoxia was defined as a peripheral oxygen saturation (SpO?) of less than 90% persisting for more than 30 seconds).; | — |
Secondary
| Measure | Time frame |
|---|---|
| The monitored parameters included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score;The recovery time (defined as the time from cessation of anesthetics to the patient's ability to correctly follow commands for nodding and tongue protrusion), the QoR-15 score at 24 hours after the procedure, as well as patient and physician satisfaction.;The incidence of adverse events and complications was recorded, including hypotension, hypertension, tachycardia, bradycardia, injection pain, hiccups, dizziness, postoperative nausea and vomiting (PONV), and intraoperative awareness. ; | — |
Countries
China
Contacts
Public ContactWang Xiaomei
People's Hospital of Ningxia Hui Autonomous Region
Outcome results
None listed