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Determination of the 90% Effective Dose of Propofol Combined with Oliceridine or Fentanyl for Inhibiting the Insertion Response in Upper Gastrointestinal Endoscopy: A Biased-Coin Up-and-Down Sequential Dose-Finding Trial

Determination of the 90% Effective Dose of Propofol Combined with Oliceridine or Fentanyl for Inhibiting the Insertion Response in Upper Gastrointestinal Endoscopy: A Biased-Coin Up-and-Down Sequential Dose-Finding Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096971
Enrollment
Unknown
Registered
2025-02-10
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

nsertion Response in Upper Gastrointestinal Endoscopy

Interventions

Oliceridine group:20ug/kg Oliceridine + Propofol
Fentanil group:1ug/kg fentanil+propofol

Sponsors

Changshu NO.2 people's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective surgery under general anesthesia; 2. Aged 18-65 years;  3. American Society of Anesthesiologists (ASA) classification I-II; 4. Body mass index (BMI): 18-30 kg/m².

Exclusion criteria

Exclusion criteria: 1. Patients with insufficient fasting time (fasting <6h, drinking <2h) or gastrointestinal obstruction with gastric content retention; 2. Patients with mental disorders, intellectual disabilities, or hearing impairments; 3. Patients with a history of long-term use of sedative and analgesic drugs, drug abuse, or alcoholism; 4. Patients with severe heart, lung, kidney, liver, or other organ dysfunction; 5. Patients with pathological obesity, myasthenia gravis, severe depression, epilepsy, or a history of psychiatric disorders; 6. Patients with uncontrolled hypertension, glaucoma, hyperthyroidism, or pheochromocytoma; 7. Patients with a history of esophageal or gastrointestinal surgery, or gastrointestinal obstruction with gastric content retention.

Design outcomes

Primary

MeasureTime frame
90% Effective Dose for Inhibiting the Insertion Response in Upper Gastrointestinal Endoscopy;

Secondary

MeasureTime frame
Incidence of adverse reactions such as pain on propofol injection, sinus bradycardia, hypotension, and body movement;Anesthesia induction time, gastrointestinal endoscopy duration, time to first body movement response or additional propofol administration, frequency and dosage of additional propofol; recovery time, defined as the time from anesthesia induction (OAAS score = 1) to the time the patient opens their eyes after the procedure;occurrence of adverse reactions during the recovery phase, including nausea, vomiting, agitation, and delirium;blood pressure, heart rate, and SpO2 at different time points: immediately after entering the endoscopy room (T1), immediately after OAAS score = 1 (T2), immediately after the endoscope enters the esophagus (T3), 2 minutes after the endoscope enters the esophagus (T4), and 1 minute after the patient wakes up (T5);

Countries

China

Contacts

Public ContactWang Qian

Changshu NO.2 people's Hospital

2703487169@qq.com+86 138 6230 8568

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026