Efficacy and Safety of Cyclopofol Versus Propofol Combined With Low-dose Sufentanil in Painless Bronchoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Dose of the Assigned Sedative Drug
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Total Dose of the Assigned Sedative Drug
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Heart Rate(Day 1)
- Peripheral Oxygen Saturation(Day 1)
- Incidence of Hypoxemia(Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1)
- Incidence of Hypotension(Periprocedural, from first study drug administration through completion of post-anesthesia recovery on Day 1)
- Incidence of Injection Pain(During intravenous administration of the study medications on Day 1)
- Incidence of Coughing(During bronchoscopy on Day 1)
- Incidence of Nausea(Periprocedural, through completion of post-anesthesia recovery on Day 1)
- Incidence of Agitation or Restlessness(Periprocedural, through completion of post-anesthesia recovery on Day 1)
- Incidence of Body Movement(During bronchoscopy on Day 1)
- Excellent-or-Good Anesthesia Rate(Immediately after completion of bronchoscopy on Day 1)
研究者
Xin'ou Chen
Principal Investigator
Wenzhou Central Hospital