Bronchoscopy, Procedural Sedation
Conditions
Keywords
Ciprofol, Propofol, Sufentanil, Painless Bronchoscopy, Procedural Sedation, Intravenous Anesthesia, Hemodynamics, Respiratory Depression
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.
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.
Interventions
DRUGPropofol
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.
DRUGSufentanil
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.
DRUGCiprofol
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.
Sponsors
Wenzhou Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Dose of the Assigned Sedative Drug | At completion of bronchoscopy on Day 1 | 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. |
| Overall Incidence of Peri-procedural Adverse Events | Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Onset Time | During induction of anesthesia on Day 1 | 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. |
| Bronchoscopy Procedure Time | During bronchoscopy on Day 1 | Duration of the bronchoscopy procedure from initiation to completion, recorded in minutes. |
| Recovery Time | During post-anesthesia recovery on Day 1 | Time from completion of bronchoscopy until the participant met the study-defined recovery or awakening criteria. The outcome was recorded in minutes. |
| Steward Recovery Score | At the post-anesthesia recovery assessment immediately following bronchoscopy on Day 1 | Post-anesthesia recovery was evaluated using the Steward recovery score. Higher scores indicated better recovery status. |
| Mean Arterial Pressure | Day 1 | Mean arterial pressure was measured in millimeters of mercury at four protocol-defined time points: T0, T1, T2, and T3. |
| Heart Rate | Day 1 | Heart rate was measured in beats per minute at four protocol-defined time points: T0, T1, T2, and T3. |
| Peripheral Oxygen Saturation | Day 1 | Peripheral oxygen saturation was measured by pulse oximetry and recorded as a percentage at four protocol-defined time points: T0, T1, T2, and T3. |
| Incidence of Hypoxemia | Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1 | The percentage of participants who experienced peripheral oxygen saturation below 90% during the procedure or recovery period. |
| Incidence of Hypotension | Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1 | The percentage of participants who developed systolic blood pressure below 90 mmHg or a decrease of more than 30% from baseline. |
| Incidence of Injection Pain | During intravenous administration of the study medications on Day 1 | The percentage of participants who experienced pain during intravenous administration of the study medications. |
| Incidence of Coughing | During bronchoscopy on Day 1 | The percentage of participants who experienced coughing during induction or bronchoscope insertion and manipulation. |
| Incidence of Nausea | Periprocedural, through completion of post-anesthesia recovery on Day 1 | The percentage of participants who experienced nausea during the bronchoscopy procedure or post-anesthesia recovery. |
| Incidence of Agitation or Restlessness | Periprocedural, through completion of post-anesthesia recovery on Day 1 | The percentage of participants who experienced agitation or restlessness during the bronchoscopy procedure or recovery period. |
| Incidence of Body Movement | During bronchoscopy on Day 1 | The percentage of participants who exhibited involuntary or purposeful body movement during sedation or bronchoscopy. |
| Excellent-or-Good Anesthesia Rate | Immediately after completion of bronchoscopy on Day 1 | 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. |
Countries
China
Outcome results
None listed