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Comparison of the efficacy and safety of different doses of oliceridine in combination with propofol in patients undergoing painless gastrointestinal endoscopy

Comparison of the efficacy and safety of different doses of oliceridine in combination with propofol in patients undergoing painless gastrointestinal endoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103013
Enrollment
Unknown
Registered
2025-05-22
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the digestive system detected by endoscopy

Interventions

Group L2:0.35mg oliceridine (5ml from saline) + 1.5-2mg/kg propofol group
Group L3:0.5mg oliceridine (5ml from saline) + 1.5-2mg/kg propofol group
Group C:Equivalent amount of saline 5ml + 1.5-2mg/kg Propofol group
Group L1:0.1mg oliceridine (5ml from saline) + 1.5-2mg/kg propofol group

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.American Society of Anesthesiologists (ASA) Class I to II; 2.Meet the indications for painless gastroenteroscopy in the 2019 edition of the Chinese Guidelines for Bowel Preparation Related to Gastrointestinal Endoscopy Diagnosis and Treatment; 3.Age 18-65 years; 18 kg/m2 <= BMI <= 30 kg/m^2; 4.Signs were stable and able to undergo painless gastroenteroscopy; 5.Communication without barriers; 6.Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Refusal to sign an informed consent form; 2.Severe respiratory depression, acute or severe bronchial asthma; 3.History of acute inflammatory disease of the respiratory tract with no cure within 2 weeks prior to signing informed consent; 4.Known or suspected gastrointestinal obstruction; 5.Known hypersensitivity to the drugs and ingredients used in this study; 6.Severe hepatic, renal, and adrenal insufficiency; 7.Long-term use of opioids; 8.An electrocardiogram suggests an abnormal QT interval; 9.The screening period predicts the likelihood of developing or having a history of difficult airway conditions, such as obstructive sleep apnea syndrome; 10.Participation in other drug trials within three months prior to signing the informed consent form; 11.History of drug and/or alcohol abuse within 1 year prior to signing the informed consent, where alcohol abuse is defined as drinking an average of more than 15 g of alcohol per day (15 g of alcohol is equivalent to 450 ml of beer or 150 ml of wine or 50 ml of light liquor).

Design outcomes

Primary

MeasureTime frame
The time of recovery of orientation;The number of cases of dizziness was recorded;The number of postoperative nausea and vomiting cases was recorded;Record the number of cases of hypotension;The number of cases of injection pain was recorded;Time of induction of anesthesia (extinction of eyelash reflex, loss of consciousness);Time of examination operation;The number of headache occurrences was recorded;Anesthesia recovery time;Record the number of cases of respiratory depression;

Secondary

MeasureTime frame
Cognitive function;Patient satisfaction ratings;Number of propofol additions and total dose;Hemodynamic parameters: heart rate (HR), blood pressure (MAP), respiratory rate (RR), oxygen saturation (SpO2);

Countries

China

Contacts

Public ContactYu Shuchun

The Second Affiliated Hospital of Nanchang University

yscdoc@163.com+86 153 9089 5160

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026