Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment

NCT06732427 | Recruiting DMC

• 1 other identifier: 2024-YCRF-M1021
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Efficacy and Safety

Keywords

Painless gastrointestinal endoscopy; fospropofol disodium for injection

Outcome Measures

Primary Outcomes (3)

• Sedation success rate

  Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 1(The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome.) or EEG bispectral index (BIS) value \<64( The rating scale ranges from levels 0 to 100, and lower BIS score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )within 5 minutes (no additional drug within 5 minutes)

  At 5 minutes after anesthetic administration

• Length of successful induction of anesthesia

  Time from the first start of administration of study drug to Modified Observer's Assessment of Alertness/Sedation score ≤1 ((The rating scale ranges from levels 0 to 5, and lower MOAA / S score indicates deeper depth of sedation, namely a higher scores mean a worse outcome.) or EEG bispectral index (BIS) value \<64(The rating scale ranges from levels 0 to 100, and lower BIS score indicates deeper depth of sedation, namely a higher scores mean a worse outcome. )

  During anesthesia

• hypoxaemia

  Oxygen saturation below 90% over 30 seconds or requires any type of airway assistance (including jaw support, artificial airway)

  During anesthesia

Secondary Outcomes (5)

• Hemodynamic index

  During anesthesia

• Limb movements of the patient during the operation

  During anesthesia

• Wake up time

  During anesthesia

• Awakening quality of anesthesia

  10 minutes ,20 minutes and 30 minutes after awakening

• Total amount of study drug used

  During anesthesia

Other Outcomes (6)

• General data of the patient(1)

  Preoperative and intraoperative

• General data of the patient(2)

  Preoperative and intraoperative

• General data of the patient(3)

  Preoperative and intraoperative

Study Arms (2)

Fospropofol Disodium

EXPERIMENTAL

Painless gastrointestinal endoscopy in group L was mainly performed using fospropofol Disodium for injection

Drug: fospropofol Disodium for injection

propofol

ACTIVE COMPARATOR

Painless gastrointestinal endoscopy in group B was mainly performed using propofol

Drug: Propofol

Interventions

fospropofol Disodium for injection DRUG

Group L received slow intravenous sufentanyl 0. 1 ug / kg +fospropofol Disodium for injection 8mg / kg (completed within 60 seconds)

Also known as: sulfentanyl

Fospropofol Disodium

Propofol DRUG

Group B received slow intravenous sufentanyl 0. 1 ug / kg +propofol 2mg / kg (completed within 60 seconds)

Also known as: sulfentanyl

propofol

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; -

You may not qualify if:

• Patients with simple and painless gastroscopy
• Allergy to this study drug and any ingredients;
• Patients with pathological obesity / obstructive sleep apnea, patients with difficult respiratory tract management;
• Acute upper respiratory tract infection and asthma attacks;
• Liver and kidney insufficiency, abnormal heart function;
• History of mental disorders, long-term use of analgesics; history of drug addiction and drug use;
• Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead
• Rugao People's Hospital: collaborator
• Qidong People's Hospital: collaborator
• Hai 'an People's Hospital: collaborator
• Rudong County Hospital of Traditional Chinese Medicine: collaborator

Study Sites (5)

Hai 'an People's Hospital

Hai’an, Jiangsu, 226600, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Qidong People's Hospital

Qidong, Jiangsu, 226200, China

NOT YET RECRUITING

Rudong County Hospital of Traditional Chinese Medicine

Rudong, Jiangsu, 226400, China

RECRUITING

Rugao People's Hospital

Rugao, Jiangsu, 226500, China

RECRUITING

MeSH Terms

Interventions

fospropofol; Injections; Sufentanil; Propofol

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Xiao MB Director of scientific research Department, Doctor

  The Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao YT Director of Department of Anesthesiology, Master

CONTACT

+86 13962988003; gyt19700114@sina.com

Liu YF project implementation PI, Master

CONTACT

+86 13506289927; winters_cool@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Using a computer-generated randomized number table, the patients were divided into two groups: group L (fospropofol disodium group) and group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists. The study drug is prepared by someone who do not participate in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 13, 2024
• Study Start: August 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)