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NCT Number: NCT07759778

Oliceridine-Propofol Dose for Gastroscope Insertion in Obese Patients

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.

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Key information

Conditions

Obesity Body Weight Gastrointestinal Endoscopy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: 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 outcomes

  1. Time to Loss of Consciousness

    Time frame: Within 5 minutes

    Time from initiation of propofol administration to loss of consciousness, defined as MOAA/S score ≤ 1.

  2. Procedure Duration

    Time frame: Periprocedural

    Total time from gastroscope insertion to completion of the endoscopic examination.

  3. Recovery Time

    Time frame: 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.

  4. Total Propofol Dose

    Time frame: Periprocedural

    Total dose of propofol administered during the entire procedure, including the initial dose and any rescue boluses.

  5. Incidence of Adverse Events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Lu

CONTACT

[email protected]

+86-15858805272

Sponsors and collaborators

Lead sponsor

Lu Yi

Other

Registry information

Official study title

Exploration of the Effective Dose of Oliceridine Combined With Propofol for Gastroscope Insertion in Obese Patients Undergoing Painless Gastrointestinal Endoscopy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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