Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients

Launched by SHANGHAI 6TH PEOPLE'S HOSPITAL · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new medication called fospropofol compared to a standard sedation medication, propofol, for elderly patients undergoing a procedure called same-day bidirectional endoscopy. Essentially, this trial aims to determine if fospropofol can provide similar or better sedation results without increasing risks for patients aged 65 and older who are scheduled for this procedure. The study will include 256 participants who will be randomly assigned to receive either fospropofol or propofol during their endoscopy.

To participate, individuals must be at least 65 years old, generally healthy (with specific health criteria), and have a body mass index within the range of 18-30. Participants can expect to receive sedation before their procedure, and the study will monitor various factors such as how quickly sedation is achieved, patient satisfaction, and any side effects experienced. This research could help guide future practices in sedation for elderly patients undergoing endoscopy, ensuring they receive safe and effective care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 65 years or older
• • American Society of Anesthesiologists (ASA) physical status I to III
• • Body mass index (BMI) 18-30 kg/m2
• • Scheduled for same-day bidirectional endoscopy under sedation
• Exclusion Criteria:
• • Severe cardiovascular, pulmonary, renal, or liver diseases
• • Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate \<50 beats/min), or hypoxemia (SpO2 \<90%)
• • Neurocognitive or psychiatric disorders
• • Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.)
• • Hypersensitivity to study medications
• • Drug or alcohol misuse
• • Definite upper respiratory tract infection
• • Refusal for participation