Trial Outcomes & Findings for Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department (NCT NCT02404610)

NCT ID: NCT02404610

Last Updated: 2021-11-30

Results Overview

adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 107 participants
• Primary outcome timeframe: From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes
• Results posted on: 2021-11-30

Participant Flow

Participant milestones

Measure	Moderate Procedural Sedation Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Deep Procedural Sedation Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol
Overall Study STARTED	54	53
Overall Study COMPLETED	54	53
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Moderate Procedural Sedation n=54 Participants Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Deep Procedural Sedation n=53 Participants Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Total n=107 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=54 Participants	0 Participants n=53 Participants	0 Participants n=107 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=54 Participants	49 Participants n=53 Participants	100 Participants n=107 Participants
Age, Categorical >=65 years	3 Participants n=54 Participants	4 Participants n=53 Participants	7 Participants n=107 Participants
Age, Continuous	41.5 years n=54 Participants	39 years n=53 Participants	40 years n=107 Participants
Sex: Female, Male Female	30 Participants n=54 Participants	25 Participants n=53 Participants	55 Participants n=107 Participants
Sex: Female, Male Male	24 Participants n=54 Participants	28 Participants n=53 Participants	52 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	54 participants n=54 Participants	53 participants n=53 Participants	107 participants n=107 Participants

PRIMARY outcome

Timeframe: From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes

Population: patients undergoing procedural sedation in the ED

adverse respiratory events measured using capnography, pulse oximetry, and airway maneuvers performed during the sedation procedure

Outcome measures

Measure	Moderate Procedural Sedation n=54 Participants Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Deep Procedural Sedation n=53 Participants Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol
Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry.	22 Participants	21 Participants

Adverse Events

Moderate Procedural Sedation

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Deep Procedural Sedation

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Moderate Procedural Sedation n=54 participants at risk Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of moderate sedation. Moderate procedural sedation is a specific term referring to procedural sedation with a target depth of moderate. Moderate Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol	Deep Procedural Sedation n=53 participants at risk Subjects will undergo procedural sedation for an indicated urgent medical procedure with a target sedation level of deep sedation. Deep procedural sedation is a specific term referring to procedural sedation with a target depth of deep. Deep Procedural Sedation with a sedative medication.: procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids. propofol
Respiratory, thoracic and mediastinal disorders adverse respiratory event	38.9% 21/54 • Number of events 30 • From 3 minutes prior to the start of the sedation encounter up until the time the patient regained their baseline mental status up to 24 hours. adverse respiratory events were defined as the occurrence of one or more clinical features of respiratory depression, including an oxygen saturation \<91%, a change in baseline ETCO2 of \>10 mm HG, or a loss of ETCO2 waveform, associated with the occurrence of any supportive airway maneuvers, including the use of a bag-valve mask apparatus, airway repositioning, the use of an oral or nasal airway to improve ventilation, or any stimulation to induce respirations.	45.3% 24/53 • Number of events 40 • From 3 minutes prior to the start of the sedation encounter up until the time the patient regained their baseline mental status up to 24 hours. adverse respiratory events were defined as the occurrence of one or more clinical features of respiratory depression, including an oxygen saturation \<91%, a change in baseline ETCO2 of \>10 mm HG, or a loss of ETCO2 waveform, associated with the occurrence of any supportive airway maneuvers, including the use of a bag-valve mask apparatus, airway repositioning, the use of an oral or nasal airway to improve ventilation, or any stimulation to induce respirations.

Additional Information

Audrey Hendrickson

Hennepin Healthcare

Phone: 6128739528

Email: audrey.hendrickson@hcmed.org

Results disclosure agreements

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