Ciprofol Versus Propofol With Low-Dose Sufentanil for Painless Bronchoscopy

NCT07744061 | Completed Phase 4

• 1 other identifier: WZCH-BRON-2022-68
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchoscopy; Procedural Sedation

Keywords

Ciprofol; Propofol; Sufentanil; Painless Bronchoscopy; Procedural Sedation; Intravenous Anesthesia; Hemodynamics; Respiratory Depression

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (15)

• Sedation Onset Time

  During induction of anesthesia on Day 1

• Bronchoscopy Procedure Time

  During bronchoscopy on Day 1

• Recovery Time

  During post-anesthesia recovery on Day 1

• Steward Recovery Score

  At the post-anesthesia recovery assessment immediately following bronchoscopy on Day 1

• Mean Arterial Pressure

  Day 1

Study Arms (2)

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.

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.

Drug: Propofol; Drug: Sufentanil

Interventions

Ciprofol DRUG

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.

Ciprofol Plus Low-Dose Sufentanil

Propofol DRUG

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.

Propofol Plus Low-Dose Sufentanil

Sufentanil DRUG

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.

Ciprofol Plus Low-Dose Sufentanil; Propofol Plus Low-Dose Sufentanil

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenzhou Central Hospital: lead

Study Sites (1)

Wenzhou Central Hospital

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol; Sufentanil

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants were unaware of their assigned sedation regimen. Outcome assessors responsible for recording vital signs, recovery indicators, anesthesia effectiveness, and adverse events were separate from the anesthesiologists administering the study medications and remained unaware of group assignment throughout data collection. The anesthesiologists administering the study drugs were not masked because the two groups received different sedative drugs and doses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication of the primary study results and remaining available for 5 years after publication.
• Access Criteria: De-identified individual participant data will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigator based on the scientific purpose of the proposed research, protection of participant privacy, and compliance with applicable ethical requirements. Where required, ethics approval and a signed data use agreement must be provided before access is granted. Approved data will be transferred through a secure electronic method and may be used only for the purposes specified in the approved proposal.

Locations

CN (1)