BronchoscopyPhase 4NCT07744061
Ciprofol Versus Propofol With Low-Dose Sufentanil for Painless Bronchoscopy
A Phase 4 study testing Ciprofol, Propofol and Sufentanil in people with Bronchoscopy and Procedural Sedation, run by Wenzhou Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Bronchoscopy, Procedural Sedation
- What is being tested?
- Ciprofol, Propofol and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2022
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Cyclopofol Versus Propofol Combined With Low-dose Sufentanil in Painless Bronchoscopy
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.
Read the detailed description
This was a prospective, single-center, randomized, parallel-group, superiority clinical study conducted at the outpatient department of Wenzhou Central Hospital. The study was designed to compare the efficacy and safety of ciprofol combined with low-dose sufentanil with those of propofol combined with low-dose sufentanil in patients undergoing bronchoscopy under intravenous sedation.
A total of 100 participants aged 35 to 65 years, weighing 45 to 80 kg, and classified as American Society of Anesthesiologists physical status I or II were enrolled. Participants were randomly assigned in a 1:1 ratio to the ciprofol group or the propofol group, with 50 participants in each group. Randomization was performed using a pre-generated random-number table. Allocation concealment was implemented using opaque, sequentially numbered, sealed envelopes that were opened immediately before administration of anesthesia.
Participants were unaware of their treatment assignment. Personnel responsible for recording vital signs, recovery indicators, and adverse events were separated from the anesthesiologists administering the study medications and from the physicians performing bronchoscopy, and remained unaware of treatment assignment during data collection.
All participants fasted for 8 hours and avoided oral fluids for 4 hours before bronchoscopy. Peripheral intravenous access was established, Ringer's acetate solution was administered at 6 to 8 mL/kg/hour, and electrocardiography, noninvasive blood pressure, heart rate, and oxygen saturation were continuously monitored. Oxygen was administered through a nasal cannula at 5 L/min.
Participants assigned to the ciprofol group received sufentanil 0.1 micrograms/kg by slow intravenous injection, followed by ciprofol 0.4 mg/kg by slow intravenous injection. Participants assigned to the propofol group received sufentanil 0.1 micrograms/kg by slow intravenous injection, followed by propofol 1.5 mg/kg by slow intravenous injection. Each study medication was administered over more than 30 seconds. Bronchoscopy was initiated after disappearance of the eyelash reflex and achievement of a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower.
The primary outcome measures were the total dose of sedative medication and the overall incidence of peri-procedural adverse events. Secondary outcome measures included sedation onset time, bronchoscopy procedure time, recovery time, Steward recovery score, mean arterial pressure, heart rate, oxygen saturation, individual adverse events, and overall anesthesia effectiveness.
This exploratory study did not include a formal prospective sample-size or statistical-power calculation. The planned sample size of 100 participants was based on the feasibility of enrollment during the study period and the sample sizes used in previous exploratory studies of intravenous sedatives for outpatient endoscopic procedures.
The study was reviewed and approved by the Ethics Committee of Wenzhou Central Hospital, approval number 2022-68. Written informed consent was obtained from all participants before enrollment.
- Conditions
- Bronchoscopy, Procedural Sedation
- Being tested
- Ciprofol, Propofol, Sufentanil
- Keywords
- Ciprofol, Propofol, Sufentanil, Painless Bronchoscopy, Procedural Sedation, Intravenous Anesthesia, Hemodynamics, Respiratory Depression
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Ciprofol 0.4 mg/kg was administered by slow intravenous injection over more than 30 seconds after sufentanil administration. Bronchoscopy was initiated after disappearance of the eyelash reflex and achievement of a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower.
PropofolDrug
Propofol 1.5 mg/kg was administered by slow intravenous injection over more than 30 seconds after sufentanil administration. Bronchoscopy was initiated after disappearance of the eyelash reflex and achievement of a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower.
SufentanilDrug
Sufentanil 0.1 micrograms/kg was administered by slow intravenous injection over more than 30 seconds before administration of the assigned sedative drug. The same sufentanil regimen was used in both intervention arms.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol Plus Low-Dose Sufentanil | Experimental | Participants received sufentanil 0.1 micrograms/kg by slow intravenous injection over more than 30 seconds, followed by ciprofol 0.4 mg/kg by slow intravenous injection over more than 30 seconds. Bronchoscopy was initiated after disappearance of the eyelash reflex and achievement of a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower. Standard physiological monitoring and supplemental oxygen were provided throughout the procedure. Receives: Drug: Ciprofol; Drug: Sufentanil |
| Propofol Plus Low-Dose Sufentanil | Active comparator | Participants received sufentanil 0.1 micrograms/kg by slow intravenous injection over more than 30 seconds, followed by propofol 1.5 mg/kg by slow intravenous injection over more than 30 seconds. Bronchoscopy was initiated after disappearance of the eyelash reflex and achievement of a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower. Standard physiological monitoring and supplemental oxygen were provided throughout the procedure. Receives: Drug: Propofol; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Dose of the Assigned Sedative Drug
The total cumulative amount of the assigned sedative drug, ciprofol or propofol, administered to each participant during the bronchoscopy procedure. The dose was recorded in milligrams.
Measured: At completion of bronchoscopy on Day 1
Overall Incidence of Peri-procedural Adverse Events
The percentage of participants who experienced at least one predefined adverse event, including hypoxemia, hypotension, injection pain, coughing, nausea, agitation or restlessness, or body movement.
Measured: Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1
Secondary outcomes (15)
Sedation Onset Time
Time from administration of the assigned sedative drug to achievement of adequate sedation, defined as disappearance of the eyelash reflex and a Modified Observer's Assessment of Alertness/Sedation score of 1 or lower. The outcome was recorded in seconds.
Measured: During induction of anesthesia on Day 1
Bronchoscopy Procedure Time
Duration of the bronchoscopy procedure from initiation to completion, recorded in minutes.
Measured: During bronchoscopy on Day 1
Recovery Time
Time from completion of bronchoscopy until the participant met the study-defined recovery or awakening criteria. The outcome was recorded in minutes.
Measured: During post-anesthesia recovery on Day 1
Steward Recovery Score
Post-anesthesia recovery was evaluated using the Steward recovery score. Higher scores indicated better recovery status.
Measured: At the post-anesthesia recovery assessment immediately following bronchoscopy on Day 1
Mean Arterial Pressure
Mean arterial pressure was measured in millimeters of mercury at four protocol-defined time points: T0, T1, T2, and T3.
Measured: Day 1
Heart Rate
Heart rate was measured in beats per minute at four protocol-defined time points: T0, T1, T2, and T3.
Measured: Day 1
Peripheral Oxygen Saturation
Peripheral oxygen saturation was measured by pulse oximetry and recorded as a percentage at four protocol-defined time points: T0, T1, T2, and T3.
Measured: Day 1
Incidence of Hypoxemia
The percentage of participants who experienced peripheral oxygen saturation below 90% during the procedure or recovery period.
Measured: Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1
Incidence of Hypotension
The percentage of participants who developed systolic blood pressure below 90 mmHg or a decrease of more than 30% from baseline.
Measured: Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1
Incidence of Injection Pain
The percentage of participants who experienced pain during intravenous administration of the study medications.
Measured: During intravenous administration of the study medications on Day 1
Incidence of Coughing
The percentage of participants who experienced coughing during induction or bronchoscope insertion and manipulation.
Measured: During bronchoscopy on Day 1
Incidence of Nausea
The percentage of participants who experienced nausea during the bronchoscopy procedure or post-anesthesia recovery.
Measured: Periprocedural, through completion of post-anesthesia recovery on Day 1
Incidence of Agitation or Restlessness
The percentage of participants who experienced agitation or restlessness during the bronchoscopy procedure or recovery period.
Measured: Periprocedural, through completion of post-anesthesia recovery on Day 1
Incidence of Body Movement
The percentage of participants who exhibited involuntary or purposeful body movement during sedation or bronchoscopy.
Measured: During bronchoscopy on Day 1
Excellent-or-Good Anesthesia Rate
The percentage of participants whose overall anesthesia effectiveness was classified as Excellent or Good. Classification was based on coughing severity, body movement, hemodynamic stability, and smoothness of the bronchoscopy procedure. Hemodynamic stability was defined as mean arterial pressure and heart rate remaining within 20% of baseline.
Measured: Immediately after completion of bronchoscopy on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Aug 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention arms. Participants in each arm received only one intravenous sedation regimen during a single bronchoscopy procedure, with no crossover between the two groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin'ou Chen, Wenzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744061
- Sponsor's protocol ID
- WZCH-BRON-2022-68
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication will be shared. The shared dataset may include demographic and baseline characteristics, treatment assignment, sedative drug doses, sedation onset time, bronchoscopy procedure time, recovery time, Steward recovery score, mean arterial pressure, heart rate, oxygen saturation at the prespecified assessment time points, individual adverse events, and the overall anesthesia effectiveness classification. Direct personal identifiers will not be shared.