Gastrointestinal Endoscopy, Obesity
Conditions
Brief summary
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.
Interventions
DRUGLow-Dose Oliceridine Group
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.
DRUGHigh-Dose Oliceridine Group
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.
Sponsors
Lu Yi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for Gastroscope Insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Loss of Consciousness | Within 5 minutes | Time from initiation of propofol administration to loss of consciousness, defined as MOAA/S score ≤ 1. |
| Procedure Duration | Periprocedural | Total time from gastroscope insertion to completion of the endoscopic examination. |
| Recovery Time | Within 30 minutes post-procedure | Time from the end of the initial propofol dose administration to the first of three consecutive MOAA/S scores of 5, indicating full alertness. |
| Total Propofol Dose | Periprocedural | Total dose of propofol administered during the entire procedure, including the initial dose and any rescue boluses. |
| Incidence of Adverse Events | From drug administration to PACU discharge | (1) Respiratory depression: SpO₂ \< 90% despite oxygen supplementation after relief of upper airway obstruction, or absence of spontaneous breathing; (2) Hypotension: mean arterial pressure (MAP) decrease \> 20% from pre-sedation baseline, or systolic blood pressure ≤ 90 mmHg, from drug administration until discharge from the post-anesthesia care unit; (3) Bradycardia: heart rate \< 50 beats per minute. |
Contacts
CONTACTYi Lu
Outcome results
None listed