Procedural Sedation
Conditions
Keywords
Arthroscopy, AV Shunt, Bunion, Dilatation and Curettage, Esophagogastroduodenoscopy, Hysteroscopy, Lithotripsy, Rotator Cuff/ Shoulder, Transesophageal Echocardiography, Ureteroscopy, AQUAVAN, Sedation
Brief summary
Very often patients receive medications before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. With respect to minimal-to-moderate procedural sedation for minor surgical procedures, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep calm (sedative). AQUAVAN is a chemically modified form of propofol, a commonly-used sedative drug. AQUAVAN acts like a slow release version of propofol, and is being studied to see if it can safely keep patients calm and relaxed during their medical procedure and then allow for rapid and clear-headed recovery.
Detailed description
This is a Phase 3 open-label, single-arm study designed to evaluate the safety of AQUAVAN following pretreatment with an analgesic, fentanyl, in patients who are undergoing minor surgical procedures that require minimal-to-moderate sedation. All patients will be placed on supplemental oxygen via nasal cannula and an electrocardiogram monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of fentanyl. Assessments will be made to evaluate the safety of AQUAVAN in patients undergoing minor surgical procedures.
Interventions
Sponsors
Eisai Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Number of sites/patients: Approximately 18 sites and 125 patients. Inclusion Criteria: 1. Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures. 2. Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) of 1996 authorization after receiving a full explanation of the extent and nature of the study. 3. Patient must be at least 18 years of age and undergoing one of the specified minor surgical procedures at the time of screening. 4. If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose. 5. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.
Exclusion criteria
1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid. 2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline. 3. Patient has a Mallampati Classification Score of 4; or a Mallampati Classification Score of 3 and a thyromental distance \<4 cm, or for any other reason has a difficult airway, in the opinion of the Principal Investigator. 4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period. 5. Patient has participated in an investigational drug study within 1 month prior to study start. 6. Patient is unwilling to adhere to pre- and postprocedural instructions. 7. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | 2 hours |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 123 |
| Total | 123 |
Baseline characteristics
| Characteristic | Fospropofol Disodium |
|---|---|
| Age Continuous | 51.3 years STANDARD_DEVIATION 15.3 |
| American Society of Anesthesiologists (ASA) status P1 ( A normal healthy patient ) | 33 participants |
| American Society of Anesthesiologists (ASA) status P2 ( A patient with mild systemic disease ) | 67 participants |
| American Society of Anesthesiologists (ASA) status P3 ( A patient with severe systemic disease ) | 22 participants |
| American Society of Anesthesiologists (ASA) status P4 (High risk, severely compromised by disease) | 1 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 particpants |
| Race/Ethnicity, Customized Asian | 1 particpants |
| Race/Ethnicity, Customized Black or African American | 9 particpants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 particpants |
| Race/Ethnicity, Customized More than one race | 0 particpants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 particpants |
| Race/Ethnicity, Customized Other | 1 particpants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 particpants |
| Race/Ethnicity, Customized White | 109 particpants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 56 Participants |
| Weight (kg) <60 | 18 participants |
| Weight (kg) >60 to <90 | 69 participants |
| Weight (kg) >90 | 36 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 111 / 123 |
| serious Total, serious adverse events | 4 / 123 |
Outcome results
Primary
Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures
Time frame: 2 hours
Population: Number of patients requiring specified types of airway assistance
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fospropofol Disodium | Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | Verbal Stimulation | 1 particpants |
| Fospropofol Disodium | Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | Loud Tone of Voice | 1 particpants |
| Fospropofol Disodium | Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | Face Mask | 1 particpants |
| Fospropofol Disodium | Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | Chin Lift | 1 particpants |
| Fospropofol Disodium | Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | Oral Airway | 1 particpants |
| Fospropofol Disodium | Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures | Increased Oxgen Flow | 2 particpants |