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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65-80
SponsorGeneral Hospital of Ningxia Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Ciprofol treatment groupExperimental treatment 1 intervention
Group B: Propofol Control groupActive comparator 1 intervention

Trial outcomes

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 Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, cardiac output , stroke volume, systemic vascular resistance , peripheral oxygen saturation, respiratory rate , end-tidal carbon dioxid within the 5-minute induction period. A comprehensive assessment of the dual safety of circulatory and respiratory systems was conducted

Time frame
5 minutes after induction of anesthesia

Secondary outcomes

1

Brain electrical activity sedation depth (BIS)

lowest BIS value throughout the induction process, BIS value immediately upon loss of consciousness.

Time frame
5 minutes after induction of anesthesia
2

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

Time frame
5 minutes after induction of anesthesia

Other outcomes

Sponsors and contacts

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