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A Comparative Study of Adverse Respiratory Reactions during Anesthesia with Propofol and Ciprofolin Elderly Daytime Surgery Patient

A Comparative Study of Adverse Respiratory Reactions during Anesthesia with Propofol and Ciprofolin Elderly Daytime Surgery Patient

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074324
Enrollment
Unknown
Registered
2023-08-03
Start date
2023-09-15
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory disease

Interventions

study group:ciprofol iv
control group:propofol iv

Sponsors

Huadong Hospital Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age greater than 60 years old; (2) American Society of Anesthesiologists (ASA) classification I-III; (3) Elderly patients undergoing elective daytime prostate biopsy under intravenous anesthesia; (4) Body mass index (BMI) =18 and =30 kg/m2; (5) Vital signs: respiratory rate =10 and =24 breaths/min; oxygen saturation (SpO2) =95% while breathing room air; (6) Able to understand the study process and methods, and voluntarily participate in the study.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to general anesthesia or a history of anesthesia accidents; (2) Patients known or suspected to be allergic or contraindicated to propofol injection, etomidate injection excipients, benzodiazepine drugs, opioid drugs, muscle relaxants, etc.; (3) Patients with acute upper respiratory tract infections, asthma attacks, or acute severe laryngeal diseases; (4) Patients with a history of gastrointestinal diseases such as gastrointestinal retention, active bleeding, and conditions that may cause reflux aspiration; (5) Patients with concurrent cerebral injury, intracranial hypertension, history of stroke or cerebrovascular accidents; (6) Patients with respiratory failure, obstructive pulmonary disease, difficult airways, or judged to have difficult tracheal intubation (modified Mallampati score III or IV); (7) Uncontrolled hypertension, hypotension, and diabetes; (8) Patients with severe arrhythmias, heart failure, unstable angina, myocardial infarction, etc.; (9) Patients with severe liver dysfunction or severe renal dysfunction; (10) Patients with a history of alcohol abuse or drug dependence; (11) Patients who abuse or have long-term use of anesthetic, sedative, or analgesic drugs; (12) Patients with a history of mental illness; (13) Patients who have participated in any drug clinical trials within one month before screening; (14) Subjects that the researcher believes have any other factors that are not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Respiratory related adverse reactions composite endpoints ( including respiratory depression, apnea, SPO2 < 93 % );

Secondary

MeasureTime frame
Duration of successful induction of anesthesia;

Countries

China

Contacts

Public ContactLiu Songbin

Huadong Hospital Hospital Affiliated to Fudan University

liusongbinmh@163.com+86 138 1893 7242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026