Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
• Intervention / Treatment: Drug: Ciprofol Injection; Drug: Propofol Injection

Detailed Description

Inclusion Criteria

1. Patients scheduled for elective non-intubated general anesthesia
2. Age ranging from 65 to 80 years old
3. American Society of Anesthesiologists (ASA) physical status class I-III
4. Written informed consent signed by the patient or legal guardian

Exclusion Criteria

1. Confirmed allergy to propofol, ciprofol or their excipients
2. Severe cardiovascular diseases (uncontrolled hypertension, heart failure, severe arrhythmia, etc.)
3. Severe respiratory diseases (chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, etc.)
4. Severe hepatic or renal insufficiency
5. Long-term regular use of sedatives or opioids
6. Baseline bradycardia (HR < 50 beats/min) or hypoxemia (SpO₂ < 90%) Elimination 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

1. Baseline BIS value and minimum BIS value during induction
2. Total induction dosage, induction time (from drug administration to MOAA/S ≤ 1), recovery time (from last drug administration to MOAA/S = 5)
3. Incidence of adverse reactions: injection pain, involuntary movement, hiccup, hypotension, bradycardia, hypoventilation, apnea, hypoxemia, etc.

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

• Hypotension (SBP < 90 mmHg or MAP decreased by >20% from baseline lasting >2 min): ephedrine 6 mg IV
• Severe bradycardia (HR < 45 beats/min lasting >30 s): atropine 0.5 mg IV
• Hypoventilation (RR < 8 bpm, PETCO₂ less than half baseline or PETCO₂ ≥45 mmHg lasting >30 s)
• Apnea (no thoracic movement or flat PETCO₂ waveform lasting >10 s)
• Hypoxemia (SpO₂ < 93%) / severe hypoxemia (SpO₂ < 85%) For respiratory compromise, jaw thrust, increased oxygen flow or mask-assisted ventilation will be applied; emergency endotracheal intubation will be performed if necessary.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hanxiang Ma Ma, master; Phone Number: 13519591508; Email: mahanxiang@hotmail.com
• Study Contact Backup: Name: LI Mo Mo, Bachelor; Phone Number: 17752025907; Email: ml185030153@163.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750000
      • Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients scheduled for elective non-intubated general anesthesia
2. Age ranging from 65 to 80 years old
3. American Society of Anesthesiologists (ASA) physical status class I-III
4. Written informed consent signed by the patient or legal guardian

Exclusion Criteria:

1. Confirmed allergy to propofol, ciprofol or their excipients
2. Severe cardiovascular diseases (uncontrolled hypertension, heart failure, severe arrhythmia, etc.)
3. Severe respiratory diseases (chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, etc.)
4. Severe hepatic or renal insufficiency
5. Long-term regular use of sedatives or opioids
6. Baseline bradycardia (HR < 50 beats/min) or hypoxemia (SpO₂ < 90%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol treatment group; 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	Drug: Ciprofol Injection; 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
Active Comparator: Propofol Control group; 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.	Drug: Propofol Injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Ciprofol; Propofol; Elderly patients; Intubation-free general anesthesia; Hemodynamics; Respiratory function
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol
• Other Study ID Numbers: Li Mo-2026-06-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No