Skip to content

Efficacy and Safety of Cisprofol Alone versus Cisprofol Combined with Fentanyl in patients undergoing upper gastrointestinal endoscopy: A Randomized, Double-blind, Controlled Trial

Efficacy and Safety of Cisprofol Alone versus Cisprofol Combined with Fentanyl in patients undergoing upper gastrointestinal endoscopy: A Randomized, Double-blind, Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088300
Enrollment
Unknown
Registered
2024-08-15
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Upper gastrointestinal endoscopy

Interventions

Intervention group:Intravenous administration of fentanyl at a dose of 1 µg/kg prior to cisprofol induction.
Placebo group:Administration of an equivalent volume of normal saline prior to cisprofol induction, matching the volume of fentanyl.

Sponsors

Yancheng No.1 People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Adults between the ages of 18-70. ASA (American Society of Anesthesiologists) Physical status I to II. Body mass index (BMI) is between 18 and 30. An elective painless esophagogastroduodenoscopy was planned.

Exclusion criteria

Exclusion criteria: History of contraindications to sedation or anesthesia, or prior adverse events related to sedation/anesthesia. Presence of severe cardiovascular or pulmonary disease. Kidney or liver dysfunction. Neurocognitive or psychiatric disorders. Pre-procedural use of sedatives or analgesics. History of alcohol abuse. Participation in any clinical drug trial within the past 3 months. Gastroscopy duration exceeding 30 minutes. Pregnant or lactating individuals. Known allergy to opioids or components of cisprofol (e.g., soybean oil, glycerol, medium-chain triglycerides, lecithin, sodium oleate, sodium hydroxide).

Design outcomes

Primary

MeasureTime frame
Success rate of sedation;

Secondary

MeasureTime frame
Induction time;Recovery time;Number of airway interventions;Incidence of hypoxemia;Incidence of hypotension;Gagging;Total dose of cisprofol injected;Postoperative pain;Postoperative fatigue;Injection pain;Postoperative nausea, vomiting, dizziness, headache, hallucinations or nightmares, pruritus, dry mouth and uroschesis. ;Patient satisfaction;Endoscopist satisfaction;Anesthesiologist satisfaction;

Countries

China

Contacts

Public ContactLu Liu

Yancheng No.1 People's Hospital

634914740@qq.com+86 180 2044 9166

Outcome results

None listed

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