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A randomized, parallel controlled clinical study to explore the efficacy and safety of cyclopofol injection and propofol injection in non-intubated general anesthesia bronchoscopy patients

A randomized, parallel controlled clinical study to explore the efficacy and safety of cyclopofol injection and propofol injection in non-intubated general anesthesia bronchoscopy patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061209
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

bronchoscope

Interventions

control group:Propofol
experimental group:Cyclopofol

Sponsors

Second Affiliated Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who plan to undergo fiberoptic bronchoscopy; 2. Plan to use non-intubated general anesthesia; 3. Gender is not limited, age >= 18 and = 90%; systolic blood pressure >= 90 mmHg; DBP >= 55 mmHg; HR 50-100 times/min; 6. The American Society of Anesthesiologists (ASA) grades I to III; 7. Able to understand the procedures and methods of this trial, willing to strictly abide by the clinical research protocol to complete this trial, and voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have anesthesia/sedation contraindications or have had anesthesia/sedation accidents in the past; 2. People who are known to be allergic to eggs, soy products, opioids and their rescue drugs, propofol, etc.; those with contraindications to propofol, opioids and their rescue drugs; 3. Patients with the following respiratory risks during screening: acute asthma attack; sleep apnea syndrome; history or family history of malignant hyperthermia; history of tracheal intubation failure; >= III); 4. During the screening period, there is a medical history of gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction, and the investigator judges that reflux may lead to aspiration; 5. Previous history of neurological and psychiatric diseases: craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history; or schizophrenia, mania, long-term use of psychotropic drugs, cognitive function History of disorders, etc.; 6. Long-term use of analgesic and sedative drugs in the past, it is not suitable to participate in this study after evaluation by the investigator; 7. Patients with severe heart, liver and kidney diseases during the screening period are not suitable to participate in this study after evaluation by the researchers; 8. Other conditions that the investigator thinks are not suitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Oxygen saturation drop rate;

Secondary

MeasureTime frame
Oxygen saturation drops;Cough score;Number of body movements;Circulatory system event rate;Onset time;Wake up time;The incidence of injection pain;Proportion of subjects receiving rescue therapy;Satisfaction ratings of patients and bronchoscopists;Satisfaction ratings of patients and bronchoscopists;Bryce Questionnaire;

Countries

China

Contacts

Public ContactMin Yan

Second Affiliated Hospital of Zhejiang University School of Medicine

zryanmin@zju.edu.cn+86 13757118632

Outcome results

None listed

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