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At the initiation of induction for non-intubated general anesthesia, ciprofol or propofol will be administered intravenously at a rate of 10 mL/min. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to evaluate sedation depth. This study aims to assess the effects of ciprofol and propofol on hemodynamics and respiratory function in elderly patients undergoing non-intubated general anesthesia.
Inclusion Criteria
Exclusion Criteria
1. Patients with allergic reactions to study drugs or other severe complications during the trial
2. Severe hypoxemia requiring emergency endotracheal intubation
3. Severe hemodynamic instability occurring during induction
4. Incomplete monitoring data caused by equipment malfunction Randomization and Group Allocation A total of 108 eligible elderly patients undergoing elective non-intubated general anesthesia at the Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University will be recruited. A computer-generated random number sequence will allocate subjects at a 1:1 ratio into the ciprofol group (Group C) and the propofol group (Group P).
Observation Indicators
Baseline Demographic Data
Gender, age, height, weight, BMI, ASA classification, smoking history, alcohol consumption, underlying diseases, Modified Mallampati score, thyromental distance, snoring history, etc.
Primary Observation Indicators
Hemodynamic parameters (HR, SBP, DBP, MAP, CO, SV, SVR) and respiratory parameters (SpO₂, respiratory rate (RR), PETCO₂) will be recorded at baseline, loss of consciousness, 30 s, 1 min, 2 min, 3 min, 4 min and 5 min after loss of consciousness.
Secondary Observation Indicators
Anesthetic Protocol
All patients fast for 8 hours and abstain from clear liquids for 4 hours preoperatively. After entering the operating room, oxygen inhalation is initiated, upper limb venous access is established, and monitors including pulse oximetry, sidestream PETCO₂ monitor, continuous non-invasive arterial blood pressure monitor and bispectral index (BIS) monitor are connected.
Midazolam 0.01 mg/kg is administered intravenously first; stable circulatory and respiratory readings thereafter serve as baseline values. Ciprofol or propofol is then infused intravenously at 10 mL/min. Sedation depth is assessed every 5 seconds via MOAA/S scale; drug infusion is stopped once MOAA/S ≤ 1 (loss of consciousness). The total induction dose is recorded. All hemodynamic and respiratory indicators are documented at predefined time points.
Anesthesiologists may supplement 1/3 of the initial induction dose if the patient shows eye opening, verbal response or body movement, with an interval of at least 1 minute between supplemental doses.
Rescue Management Protocols
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol treatment group | Experimental | This group plans to enroll a total of 54 elderly patients aged 65-80 who will undergo brief procedures without intubation, using spontaneous respiration under general anesthesia. The intravenous infusion of cyclopropane hydrochloride injection will be administered at a constant rate of 10 ml/min. The administration will cease when the MOAA/S score is ≤1. Throughout the procedure, hemodynamic parameters (HR, SBP, DBP, MAP, CO, SV,SVR), and respiratory parameters (SpO₂, respiratory rate (RR), PETCO₂), and various anesthetic adverse reactions will be monitored within the first 5 minutes after induction. The safety of the medication will be evaluated in comparison with the control group |
|
| Propofol Control group | Active Comparator | This study aims to enroll 54 elderly patients aged 65-80 with short procedures and no need for intubation, who will receive propofol intravenously at a constant rate of 10 ml/min until their MOAA/S score drops to ≤1 point. Circulatory and respiratory parameters, as well as adverse events, will be recorded simultaneously 5 minutes after induction. This will allow for a parallel comparison of the two medications' effects on the circulatory and respiratory systems of elderly patients with the propofol control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol Injection | Drug | Intravenous administration, injection rate of 10 ml/min, continuous and uniform infusion until the patient's MOAA/S sedation score is ≤1 point. This is used for the induction of general anesthesia in short-duration medical procedures for elderly individuals aged 65-80 without intubation and with spontaneous respiration |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of hemodynamic and respiratory function changes within 5 minutes of anesthesia induction | The primary objective of this study was to evaluate the degree of circulatory and respiratory suppression induced by two types of anesthesia drugs in elderly patients. Continuous, non-invasive monitoring was conducted on the baseline conditions before administration for patients aged 65 to 80 undergoing short procedures without intubation and with spontaneous respiration under general anesthesia. Additionally, measurements were taken at 1 minute, 2 minutes, 3 minutes, 4 minutes, and 5 minutes after induction to assess circulatory and respiratory functions. Statistical analysis was performed to compare the changes in HR, SBP, DBP, MAP, CO, SV, SVR, PETCO2, RR, and SPO2 within the 5-minute induction period. A comprehensive assessment of the dual safety of circulatory and respiratory systems was conducted | 5 minutes after induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Brain electrical activity sedation depth (BIS) | lowest BIS value throughout the induction process, BIS value immediately upon loss of consciousness. | 5 minutes after induction of anesthesia |
| incidence of induction period circulatory/respiratory adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanxiang Ma Ma, master | Contact | 13519591508 | mahanxiang@hotmail.com | |
| LI Mo Mo, Bachelor | Contact | 17752025907 | ml185030153@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750000 | China |
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| Ciprofol Injection | Drug | Intravenous administration, injection rate of 10 ml/min, continuous and uniform infusion until the patient's MOAA/S sedation score is ≤1 point. This is used for the induction of general anesthesia in short-duration medical procedures for elderly individuals aged 65-80 without intubation and with spontaneous respiration |
|
Proportion of adverse events, including low blood pressure, bradycardia, inadequate ventilation, apnea, and hypoxemia, occurring within 5 minutes of induction |
| 5 minutes after induction of anesthesia |
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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