Trial Outcomes & Findings for Propofol vs Propofol + Benzo/Opiates in High Risk Group (NCT NCT01315158)
NCT ID: NCT01315158
Last Updated: 2016-10-28
Results Overview
In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
One day (during procedure)
Results posted on
2016-10-28
Participant Flow
Participant milestones
| Measure |
Propofol+Benzo/Opioids
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propofol vs Propofol + Benzo/Opiates in High Risk Group
Baseline characteristics by cohort
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One day (during procedure)In high risk patients (meeting at least of 1 of 3 criteria: ASA ≥ 3, BMI ≥ 30, those at risk for OSA) undergoing advanced endoscopy procedures, compare the number of participants who experience airway maneuvers (AMs) when sedated with propofol alone versus propofol in combination with benzodiazepines and opioids.
Outcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Number of Participants Who Experience Airway Maneuvers
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: One day (during procedure)Compare the number of participants who experience other sedation related complications such as hypotension, hypoxemia and need for termination of the procedure between the two groups
Outcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Number of Participants Who Experience Other Sedation Related Complications
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: One day (during procedure)Population: The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.
The dose of propofol used between the two groups will be compared
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Predictors of Sedation Related Complications as Measured by the Number of Participants Who Experience Hypoxemia (Defined as a Pulse Oximetry <90% for Any Duration)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Predictors of Sedation Related Complications as Measured by Hypopnea/Apnea (Defined as Fewer Than 6 Breaths/Minute Based on Capnography)
|
0 incidences
|
0 incidences
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Predictors of Sedation Related Complications as Measured by the Incidences of Hypotension (Defined as Systolic Blood Pressure of Less Than 90mmHg or a Decrease of More Than 25% From Baseline)
|
0 incidences
|
0 incidences
|
SECONDARY outcome
Timeframe: One yearOutcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Predictors of Sedation Related Complications as Measured by Early Procedure Termination for an Alternative Sedation Related Complication
|
0 incidences
|
0 incidences
|
SECONDARY outcome
Timeframe: 24-48 hoursPopulation: The data for this outcome measure was not collected and was not analyzed due to not having the necessary support to continue the study.
The frequency of symptoms of nausea and vomiting in the two groups of patients will be recorded. Patient tolerance of the procedure will be assessed independently by the endoscopist using a 100-mm visual analog scale (VAS, 0=unmanageable, 100=excellent). The patient will also score the level of tolerance using the same VAS at a routine follow-up phone call made 24-48 hours after the procedure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24-48 hoursThe number of participants who experience symptoms of nausea and vomiting in the two groups of patients will be recorded. This will be recorded during the follow-up phone call made 24-48 hours after the procedure.
Outcome measures
| Measure |
Propofol+Benzo/Opioids
n=17 Participants
If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:
1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2. Recommended Fentanyl
1. Prior to intubation = 0.5 ug/kg
2. Total procedural dose = 1 ug/kg
Propofol+Benzo/Opioids: 1. Recommended Versed:
a. Prior to intubation
* patient is \< 50 kg = 1 mg Versed
* patient is 50-75 kg = 1.5 mg Versed
* patient is \> 75 kg = 2 mg Versed
2\. Recommended Fentanyl
a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg
|
Propofol Alone
n=19 Participants
The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:
* Induction Dose: 2-2.5 mg/kg
* Maintenance Dose: 0.1-0.2 mg/kg/min
Propofol Alone: Recommended Propofol doses before considering crossover:
* Induction: 2-2.5 mg/kg
* Maintenance: 0.1-0.2 mg/kg/min
|
|---|---|---|
|
Number of Participants Who Experience Symptoms of Nausea and Vomiting Will be Compared Between the Two Groups
|
2 participants
|
1 participants
|
Adverse Events
Propofol+Benzo/Opioids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place