CompletedPhase 4

Ciprofol Versus Propofol With Low-Dose Sufentanil for Painless Bronchoscopy

China100 participantsStarted 2022-08-01

Plain-language summary

Bronchoscopy may cause coughing, discomfort, body movement, and changes in breathing or blood pressure. Propofol is commonly used for sedation during bronchoscopy, but it may cause respiratory depression, circulatory depression, and injection pain. Ciprofol is another intravenous sedative that may provide effective sedation with fewer adverse effects. This study compared ciprofol combined with low-dose sufentanil with propofol combined with low-dose sufentanil in adults undergoing bronchoscopy under intravenous sedation. A total of 100 adults aged 35 to 65 years with no or mild systemic disease were randomly assigned in a 1:1 ratio to two treatment groups. Participants in one group received ciprofol and low-dose sufentanil, while participants in the other group received propofol and low-dose sufentanil. The study evaluated the amount of sedative used, adverse events, sedation onset time, recovery time, recovery quality, blood pressure, heart rate, oxygen saturation, and the overall effectiveness of anesthesia.

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 35 to 65 years. * Body weight 45 to 80 kg. * American Society of Anesthesiologists physical status I or II. * Scheduled to undergo painless bronchoscopy. * No contraindications to intravenous anesthesia. * Willing and able to cooperate with study procedures. * Provided written informed consent. Exclusion Criteria: * Body mass index greater than 40 kg/m². * Uncontrolled hypertension, defined as systolic blood pressure greater than 180 mmHg. * Severe cardiac arrhythmia. * Unstable angina. * Acute myocardial infarction within the previous 3 months. * Acute exacerbation of asthma. * Moderate to severe chronic obstructive pulmonary disease. * Known allergy or hypersensitivity to any study anesthetic medication. * Full-stomach status, intestinal obstruction, or gastric retention. * Coagulation dysfunction or a clinically significant bleeding tendency. * Mental illness or cognitive impairment that prevented cooperation with study procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Dose of the Assigned Sedative Drug

Timeframe: At completion of bronchoscopy on Day 1

Overall Incidence of Peri-procedural Adverse Events

Timeframe: Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1

Trial details

NCT IDNCT07744061

SponsorWenzhou Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Bronchoscopy trials