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

NCT07670923 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Li Mo-2026-06-22
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Ciprofol; Propofol; Elderly patients; Intubation-free general anesthesia; Hemodynamics; Respiratory function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Brain electrical activity sedation depth (BIS)

  5 minutes after induction of anesthesia

• incidence of induction period circulatory/respiratory adverse events

  5 minutes after induction of anesthesia

Study Arms (2)

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

Drug: Ciprofol Injection

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.

Drug: Propofol Injection

Interventions

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

Propofol Control group

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

Ciprofol treatment group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Propofol; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Hanxiang Ma Ma, master

CONTACT

13519591508; mahanxiang@hotmail.com

LI Mo Mo, Bachelor

CONTACT

17752025907; ml185030153@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

CN (1)