A Study to Assess the Efficacy and Safety of Fospropofol Disodium

Phase 1

Completed

• Conditions: Drug Safety
• Interventions: Drug: Fospropofol disodium

• Registration Number: NCT01271569
• Lead Sponsor: West China Hospital

Brief Summary

The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index \[BIS\]) and to compare the dynamic properties of PropofolF to those of Propofol.

Detailed Description

After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine. Ingestion of caffeine, alcohol, products containing aspartame (aspartame may increase formate concentrations), or use of paracetamol within 24 h before study drug administration resulted in ineligibility. Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-05
• Last Update Submitted: 2011-01-05
• Study First Posted: 2011-01-06
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine.

Exclusion Criteria

• Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
In the treatment arm	Fospropofol disodium	-

Primary Outcome Measures

Name	Time	Method
BIS	2hr after administration

Secondary Outcome Measures

Name	Time	Method
Modified OAA/S Score	2hr after administration

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China