Sedation during elective colonoscopy
Conditions
Interventions
Product Name: ABP-700
Product Code: ABP-700
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: ABP-700
Other descriptive name: ABP-700
Concentratio
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must be male or female 18 -75 years of age, inclusive. 2. Patient must give written informed consent before initiation of any study-related procedures 3. Patient is scheduled to undergo elective colonoscopy 4. BMI 18.0 – 29.0 kg/m2 5. ASA class I – II 6. Modified Mallampati score I – II Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Any ASA physical status III or worse, or history of one or more of the following: - History or presence of significant cardiovascular disease including atrial fibrillation, or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome, > 450 msec) - History of any neurological or seizure disorder or psychiatric disease - History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic or dermatologic disease - History of any illness that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the patient by their participation in the study 2. History of any recent illness (e.g., upper respiratory infection) that does not satisfy ASA III or greater requirements but in the opinion of the PI, may pose an additional risk to the patient by their participation in the study. 3. Patients with a history of essential hypertension that are not well on controlled on medication and/or have been diagnosed with hypertension for less than 6 months and/or are not on stable therapy for at least 4 weeks prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the dose-response relationship, efficacy and safety of ABP-700 for procedural sedation in adult patients undergoing colonoscopy. • To quantify the pharmacodynamic effect of ABP-700 including time to procedure start, sedation depth, patient recovery and readiness for discharge • To quantify the cardio-respiratory effects of sedation doses of ABP-700 ;Secondary Objective: Exploratory objectives: To determine endoscopist and anesthesiologist satisfaction with the procedure To determine patient satisfaction with the procedure To determine patient procedural recall. To evaluate cognition and memory function of the patient.;Timepoint(s) of evaluation of this end point: At the end of the procedure or before discharge;Primary end point(s): Efficacy endpoints: • Number of successfully completed procedures by assigned ABP-700 infusion dose. Success defined as patients who meet the following 2 criteria: • Procedure completion • No significant respiratory depression as assessed by oxygen saturation decrease to less than 90% and no need for assisted positive pressure ventilation (manual or mechanical) • Number of successfully completed procedures (as above) by assigned ABP-700 infusion dose with and without bolus ABP-700 adjustment • Number of successfully completed procedures by assigned ABP-700 infusion dose with and without bolus ABP-700 adjustment that require or do not require rescue sedative medication. • Time to procedure start • Depth and duration of sedation • Number of supplemental ABP-700 bolus doses required Recovery from sedation and discharge conditions as assessed by the Modified Aldrete score (APRS) Safety endpoints: • Quantification of hemodynamics to include frequency of adverse events and change from baseline for heart rate, blood pressure and ECG parameters (e.g. QTc) • Frequency of MOAA/S 30s) and patients who require maneuvers to open or maintain the airway (e.g. chin lift, jaw thrust) and any mechanical or hand assisted ventil | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N.A.;Timepoint(s) of evaluation of this end point: N.A. | — |
Countries
Netherlands
Contacts
Public ContactSteven Sweeney
The Medicines Company
Outcome results
None listed