Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete. This is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 50-65 years, weight 40-65kg, male or female;

• Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;

• American Society of Anesthesia (ASA) grades I-II;

• Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -

Locations
Other Locations
China
Hai 'an People's Hospital
RECRUITING
Hai’an
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Qidong People's Hospital
NOT_YET_RECRUITING
Qidong
Rudong County Hospital of Traditional Chinese Medicine
RECRUITING
Rudong
Rugao People's Hospital
RECRUITING
Rugao
Contact Information
Primary
Gao YT Director of Department of Anesthesiology, Master
gyt19700114@sina.com
+86 13962988003
Backup
Liu YF project implementation PI, Master
winters_cool@126.com
+86 13506289927
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 426
Treatments
Experimental: Fospropofol Disodium
Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection
Active_comparator: propofol
Painless gastrointestinal endoscopy in group B was mainly performed using propofol
Related Therapeutic Areas
Sponsors
Collaborators: Hai 'an People's Hospital, Qidong People's Hospital, Rugao People's Hospital, Rudong County Hospital of Traditional Chinese Medicine
Leads: Affiliated Hospital of Nantong University

This content was sourced from clinicaltrials.gov