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A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00327392
Recruitment Status : Completed
First Posted : May 18, 2006
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by:
Eisai Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Procedural Sedation
Intervention Drug: AQUAVAN® (fospropofol disodium) Injection
Enrollment 123
Recruitment Details This study recruited at 12 study centers in the US during the period of 22-Jun-2006 to 01 Mar 2007.
Pre-assignment Details All subjects received fentanyl at an initial dose of 50 μg as an analgesic pretreatment 5 minutes prior to the administration of the initial dose of fospropofol disodium (also referred to as LUSEDRA and formerly known as AQUAVAN). After fentanyl administration, the venous catheter was flushed with 2 mL of sterile saline solution.
Arm/Group Title Fospropofol Disodium
Hide Arm/Group Description Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
Period Title: Overall Study
Started 123
Completed 123
Not Completed 0
Arm/Group Title Fospropofol Disodium
Hide Arm/Group Description Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
Overall Number of Baseline Participants 123
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants
51.3  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants
Female
67
  54.5%
Male
56
  45.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Particpants
Number Analyzed 123 participants
American Indian or Alaska Native 0
Asian 1
Native Hawaiian or Other Pacific Islander 0
Black or African American 9
White 109
More than one race 0
Unknown or Not Reported 0
Hispanic/Latino 3
Other 1
Weight (kg)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants
<60 18
>60 to <90 69
>90 36
American Society of Anesthesiologists (ASA) status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 123 participants
P1 ( A normal healthy patient ) 33
P2 ( A patient with mild systemic disease ) 67
P3 ( A patient with severe systemic disease ) 22
P4 (High risk, severely compromised by disease) 1
1.Primary Outcome
Title Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
Hide Description [Not Specified]
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients requiring specified types of airway assistance
Arm/Group Title Fospropofol Disodium
Hide Arm/Group Description:
Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: particpants
Verbal Stimulation 1
Loud Tone of Voice 1
Face Mask 1
Chin Lift 1
Oral Airway 1
Increased Oxgen Flow 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fospropofol Disodium
Hide Arm/Group Description Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
All-Cause Mortality
Fospropofol Disodium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fospropofol Disodium
Affected / at Risk (%)
Total   4/123 (3.25%) 
Cardiac disorders   
Cardiac arrest  1/123 (0.81%) 
Congenital, familial and genetic disorders   
Atrial septal defect  2/123 (1.63%) 
Investigations   
Ammonia increased  1/123 (0.81%) 
Nervous system disorders   
Hepatic encephalopathy  1/123 (0.81%) 
Respiratory, thoracic and mediastinal disorders   
Apnoea  1/123 (0.81%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fospropofol Disodium
Affected / at Risk (%)
Total   111/123 (90.24%) 
Gastrointestinal disorders   
Constipation  3/123 (2.44%) 
Nausea  10/123 (8.13%) 
Vomiting  7/123 (5.69%) 
Injury, poisoning and procedural complications   
Procedural pain  62/123 (50.41%) 
Nervous system disorders   
Dizziness  3/123 (2.44%) 
Headache  4/123 (3.25%) 
Paresthesia  66/123 (53.66%) 
Tremor  2/123 (1.63%) 
Reproductive system and breast disorders   
Uterine spasm  4/123 (3.25%) 
Respiratory, thoracic and mediastinal disorders   
Nasal discomfort  2/123 (1.63%) 
Pharyngolaryngeal pain  2/123 (1.63%) 
Skin and subcutaneous tissue disorders   
Pruritus  32/123 (26.02%) 
Vascular disorders   
Hypotension  5/123 (4.07%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Eisai Medical Services
Organization: Eisai Inc
Phone: 1-888-422-4743
ClinicalTrials.gov Identifier: NCT00327392     History of Changes
Other Study ID Numbers: 3000-0523
First Submitted: May 16, 2006
First Posted: May 18, 2006
Results First Submitted: March 1, 2012
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012