Trial Outcomes & Findings for A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures. (NCT NCT00327392)

NCT ID: NCT00327392

Last Updated: 2012-06-20

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 123 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2012-06-20

Participant Flow

This study recruited at 12 study centers in the US during the period of 22-Jun-2006 to 01 Mar 2007.

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.

Participant milestones

Measure	Fospropofol Disodium 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 Study STARTED	123
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fospropofol Disodium n=123 Participants 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.
Age Continuous	51.3 years STANDARD_DEVIATION 15.3 • n=93 Participants
Sex: Female, Male Female	67 Participants n=93 Participants
Sex: Female, Male Male	56 Participants n=93 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 particpants n=93 Participants
Race/Ethnicity, Customized Asian	1 particpants n=93 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 particpants n=93 Participants
Race/Ethnicity, Customized Black or African American	9 particpants n=93 Participants
Race/Ethnicity, Customized White	109 particpants n=93 Participants
Race/Ethnicity, Customized More than one race	0 particpants n=93 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 particpants n=93 Participants
Race/Ethnicity, Customized Hispanic/Latino	3 particpants n=93 Participants
Race/Ethnicity, Customized Other	1 particpants n=93 Participants
Weight (kg) <60	18 participants n=93 Participants
Weight (kg) >60 to <90	69 participants n=93 Participants
Weight (kg) >90	36 participants n=93 Participants
American Society of Anesthesiologists (ASA) status P1 ( A normal healthy patient )	33 participants n=93 Participants
American Society of Anesthesiologists (ASA) status P2 ( A patient with mild systemic disease )	67 participants n=93 Participants
American Society of Anesthesiologists (ASA) status P3 ( A patient with severe systemic disease )	22 participants n=93 Participants
American Society of Anesthesiologists (ASA) status P4 (High risk, severely compromised by disease)	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: Number of patients requiring specified types of airway assistance

Outcome measures

Measure	Fospropofol Disodium n=7 Participants 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.
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures Verbal Stimulation	1 particpants
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures Loud Tone of Voice	1 particpants
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures Face Mask	1 particpants
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures Chin Lift	1 particpants
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures Oral Airway	1 particpants
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures Increased Oxgen Flow	2 particpants

Adverse Events

Fospropofol Disodium

Serious events: 4 serious events

Other events: 111 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fospropofol Disodium n=123 participants at risk 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.
Cardiac disorders Cardiac arrest	0.81% 1/123
Congenital, familial and genetic disorders Atrial septal defect	1.6% 2/123
Investigations Ammonia increased	0.81% 1/123
Nervous system disorders Hepatic encephalopathy	0.81% 1/123
Respiratory, thoracic and mediastinal disorders Apnoea	0.81% 1/123

Other adverse events

Measure	Fospropofol Disodium n=123 participants at risk 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.
Gastrointestinal disorders Constipation	2.4% 3/123
Gastrointestinal disorders Nausea	8.1% 10/123
Gastrointestinal disorders Vomiting	5.7% 7/123
Injury, poisoning and procedural complications Procedural pain	50.4% 62/123
Nervous system disorders Dizziness	2.4% 3/123
Nervous system disorders Headache	3.3% 4/123
Nervous system disorders Paresthesia	53.7% 66/123
Nervous system disorders Tremor	1.6% 2/123
Reproductive system and breast disorders Uterine spasm	3.3% 4/123
Respiratory, thoracic and mediastinal disorders Nasal discomfort	1.6% 2/123
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.6% 2/123
Skin and subcutaneous tissue disorders Pruritus	26.0% 32/123
Vascular disorders Hypotension	4.1% 5/123

Additional Information

Eisai Medical Services

Eisai Inc

Phone: 1-888-422-4743

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place