Oliceridine-Propofol Dose for Gastroscope Insertion in Obese Patients

NCT07759778 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: SAHoWMU-CR2026-03-117
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Gastrointestinal Endoscopy

Outcome Measures

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.

  Within 3 minutes after gastroscope insertion

Secondary Outcomes (5)

• 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

Study Arms (2)

Low-Dose Oliceridine Group

EXPERIMENTAL

Drug: Low-Dose Oliceridine Group

High-Dose Oliceridine Group

EXPERIMENTAL

Drug: High-Dose Oliceridine Group

Interventions

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.

Low-Dose Oliceridine Group

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.

High-Dose Oliceridine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lu Yi: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Lu

CONTACT

+86-15858805272; luyi1111.cool@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share