Oliceridine-Propofol Dose for Gastroscope Insertion in Obese Patients
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLu Yi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Dose Oliceridine Group
DrugOliceridine 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
DrugOliceridine 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Low-Dose Oliceridine GroupExperimental treatment 1 intervention
Group B: High-Dose Oliceridine GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effective Dose (ED50 and ED95) of Propofol Combined with Oliceridine for 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.
Time frame
Within 3 minutes after gastroscope insertionSecondary outcomes
1
Time to Loss of Consciousness
Time from initiation of propofol administration to loss of consciousness, defined as MOAA/S score ≤ 1.
Time frame
Within 5 minutes2
Procedure Duration
Total time from gastroscope insertion to completion of the endoscopic examination.
Time frame
Periprocedural3
Recovery Time
Time from the end of the initial propofol dose administration to the first of three consecutive MOAA/S scores of 5, indicating full alertness.
Time frame
Within 30 minutes post-procedure4
Total Propofol Dose
Total dose of propofol administered during the entire procedure, including the initial dose and any rescue boluses.
Time frame
PeriproceduralLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lu Yi
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Sponsor institution
Source ClinicalTrials.gov
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