Clinical trial

Oliceridine-Propofol Dose for Gastroscope Insertion in Obese Patients

Opening soon · Phase 4 · 0 countries · Registry ID NCT07759778

Opening soonPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Gastrointestinal Endoscopy

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments and study arms

Low-Dose Oliceridine Group

Drug

Oliceridine at a low fixed dose is administered intravenously, followed by propofol at an initial dose of 2 mg/kg based on lean body weight.

High-Dose Oliceridine Group

Drug

Oliceridine at a high fixed dose is administered intravenously, followed by propofol at an initial dose of 1.5 mg/kg based on lean body weight.

Primary outcomes

Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope InsertionWithin 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.

Study locations

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No public site location was included in this record. Check the original registry for updates.