Exploration of the Effective Dose of Oliceridine Combined With Propofol for Gastroscope Insertion in Obese Patients Undergoing Painless Gastrointestinal Endoscopy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion
研究概览
简要总结
The purpose of this study is to find the right dose of two medications, oliceridine and propofol, when used together for sedation in patients with obesity undergoing a painless gastroscope procedure.
Currently, standard sedation methods using other opioids can sometimes cause breathing problems, especially in patients with obesity. Oliceridine is a newer medication that may provide good pain relief with a lower risk of these side effects. However, the best dose of propofol when combined with oliceridine for this specific patient group is not yet clear.
This study will enroll patients with obesity (BMI ≥ 28 kg/m²) who are scheduled for a routine painless gastroscopy. Participants will receive the study medications during their procedure, and the medical team will carefully monitor their vital signs and sedation level. The study aims to find the most effective and safe dose combination to help guide future clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old, regardless of sex
- •BMI≥28 kg/m2
- •The American Society of Anesthesiologists (ASA) has a rating of II-III
- •Plan to undergo elective painless digestive endoscopy
- •The subjects understand the purpose and steps of this experiment, voluntarily participate in this experiment, and sign a written informed consent
排除标准
- •Known to be allergic to drugs used in the examination process
- •Diagnosed respiratory diseases (asthma, bronchitis, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer or upper respiratory tract infection)
- •Cardiovascular diseases (heart failure, unstable angina pectoris, myocardial infarction or arrhythmia) have been diagnosed
- •Current hepatic insufficiency (Child-Pugh grade B or above) or renal insufficiency (estimated glomerular filtration rate < 60 ml/min/1.73 m2)
- •History of difficult airway (Mallampati Grade IV or expected difficult airway)
- •Long-term use of opioids (regular use of opioids for more than 7 days within 3 months before operation)
- •Pregnant or lactating women
- •Mental illness or cognitive dysfunction can not cooperate
研究组 & 干预措施
Low-Dose Oliceridine Group
干预措施: Low-Dose Oliceridine Group (Drug)
High-Dose Oliceridine Group
干预措施: High-Dose Oliceridine Group (Drug)
结局指标
主要结局
Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion
时间窗: Within 3 minutes after gastroscope insertion
The ED50 and ED95 of propofol (based on lean body weight) required to achieve successful sedation during gastroscope insertion, estimated using the biased coin design up-and-down method with isotonic or central ordered regression. Positive response is defined as: cough or body movement ≥ grade 2 during gastroscope insertion, requiring additional propofol.
次要结局
- Time to Loss of Consciousness(Within 5 minutes)
- Procedure Duration(Periprocedural)
- Recovery Time(Within 30 minutes post-procedure)
- Total Propofol Dose(Periprocedural)
- Incidence of Adverse Events(From drug administration to PACU discharge)
研究者
Lu Yi
Principal Investigator
Second Affiliated Hospital of Wenzhou Medical University