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The primary aim of this study is to compare the propofol requirements of children who receive propofol with that of children who receive dexmedetomidine prior to propofol, for sedation for upper and lower endoscopic procedures.
Both propofol and dexmedetomidine may be used to achieve adequate sedation conditions. Propofol has been described to produce successful conditions for completion of the intended study in almost 99% of the patients. However, in a study that reviewed outcomes when using propofol for almost 50,000 pediatric procedures, propofol was associated with stridor, laryngospasm, airway obstruction, wheezing or central apnea at a rate of 1 in 65 sedations. The need for airway and ventilation interventions which include oral/nasal airway placement, positive pressure mask ventilation and tracheal intubation occurred at a rate of 1 in 70 sedations. Hemodynamic and respiratory fluctuations of a minimum of 30% fluctuations in heart rate, blood pressure or respiratory rate occurred at a rate of 1 in 165 sedations. Another recent study cited similar incidences of hemodynamic variability with propofol as well as inhalational anesthesia in the outpatient pediatric setting.
Until 2015, dexmedetomidine had been one of the standard drugs administered for sedation in children who require radiologic diagnostic imaging studies (MRI, CT and Nuclear Medicine) in the Department of Radiology at Boston Children's Hospital (BCH). Over 17,000 infants, children and developmentally compromised young adults had been sedated with dexmedetomidine in BCH without a cardiac or respiratory arrest, or a need to provide positive pressure assisted ventilation.
This study will determine if administration of dexmedetomidine with propofol administration will result in lower doses of the latter, which may mean safer outcomes in sedation for upper and lower endoscopic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol (Group P) | Active Comparator | Propofol only |
|
| Propofol with Dexmedetomidine (Group DP) | Active Comparator | Propofol with Dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patients in Group DP will receive 0.5 mcg/kg Dexmedetomidine (DEX) administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of Bispectral Index (BIS) 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. | Compare the total propofol requirements (in mg/kg/min) of children who receive intravenous propofol with pre-treatment of dexmedetomidine with the propofol requirements in children who do not receive dexmedetomidine. | up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events and the Need for Airway Interventions | To compare propofol to dexmedetomidine with respect to the frequency of adverse events and the need for airway interventions | 1 day |
| Time Required to Achieve Sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keira Mason, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33009191 | Derived | Mason KP, Park RS, Sullivan CA, Lukovits K, Halpin EM, Imbrescia ST, Cavanaugh D, Prescilla R, Fox VL. The synergistic effect of dexmedetomidine on propofol for paediatric deep sedation: A randomised trial. Eur J Anaesthesiol. 2021 May 1;38(5):541-547. doi: 10.1097/EJA.0000000000001350. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol (Group P) | Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a Bispectral Index (BIS) of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50. |
| FG001 | Propofol With Dexmedetomidine (Group DP) | Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg Dexmedetomidine (DEX) bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol (Group P) | Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. | Compare the total propofol requirements (in mg/kg/min) of children who receive intravenous propofol with pre-treatment of dexmedetomidine with the propofol requirements in children who do not receive dexmedetomidine. | Posted | Median | Inter-Quartile Range | mg/kg/min | up to 3 hours |
|
Adverse event data were collected for each patient for up to 3 days, starting from the time of first drug administration (DEX or propofol).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol (Group P) | Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Question of Bronchospasm and laryngospam | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Oxygen desaturation (75 to 90%) for less than 60s, requiring two interventions: additional sedative was administered (minimal risk) and bag-valve mask-assisted ventilation (moderate risk). No other unintended events occurred. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keira Mason | Boston Children's Hospital | (617) 355-7737 | keira.mason@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2018 | May 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Propofol (Group P) | Drug | Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50. |
|
| Propofol (Group DP) | Drug | Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. |
|
To compare propofol to dexmedetomidine with respect to the time required to receive sedation
| up to 30 minutes |
| Time Required to Meet Discharge Criteria From Recovery Room | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the time required to meet discharge criteria from recovery room | up to 4 hours |
| Adverse Events | To compare the propofol-only group to dexmedetomidine-propofol group with respect to adverse events | 3 days |
| Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the need for unplanned airway interventions | up to 3 hours |
| Emergence Delirium | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the Pediatric Anesthesia Emergence Delirium (PAED) score. The PAED is a scale that measures emergence delirium in children and adolescence as they wake up from anesthesia. The lowest achievable score is 0 and is consistent with no emergence delirium (best outcome). The highest achievable score is 20 and is consistent with emergence delirium (worse outcome). | up to 4 hours |
| Time to BIS Score | To compare the propofol-only group to dexmedetomidine-propofol group with respect to time (in minutes) of return of BIS score to baseline (pre-sedation level) in recovery room | up to 6 hours |
| Duration of Sedation | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the duration of sedation | up to 3 hours |
| BG001 | Propofol With Dexmedetomidine (Group DP) | Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Propofol With Dexmedetomidine (Group DP) |
Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. |
|
|
| Secondary | Frequency of Adverse Events and the Need for Airway Interventions | To compare propofol to dexmedetomidine with respect to the frequency of adverse events and the need for airway interventions | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Time Required to Achieve Sedation | To compare propofol to dexmedetomidine with respect to the time required to receive sedation | Posted | Mean | Full Range | minutes | up to 30 minutes |
|
|
|
| Secondary | Time Required to Meet Discharge Criteria From Recovery Room | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the time required to meet discharge criteria from recovery room | Posted | Mean | Full Range | minutes | up to 4 hours |
|
|
|
| Secondary | Adverse Events | To compare the propofol-only group to dexmedetomidine-propofol group with respect to adverse events | Posted | Count of Participants | Participants | 3 days |
|
|
|
| Secondary | Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the need for unplanned airway interventions | Posted | Count of Participants | Participants | up to 3 hours |
|
|
|
| Secondary | Emergence Delirium | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the Pediatric Anesthesia Emergence Delirium (PAED) score. The PAED is a scale that measures emergence delirium in children and adolescence as they wake up from anesthesia. The lowest achievable score is 0 and is consistent with no emergence delirium (best outcome). The highest achievable score is 20 and is consistent with emergence delirium (worse outcome). | Posted | Count of Participants | Participants | up to 4 hours |
|
|
|
| Secondary | Time to BIS Score | To compare the propofol-only group to dexmedetomidine-propofol group with respect to time (in minutes) of return of BIS score to baseline (pre-sedation level) in recovery room | Posted | Mean | Full Range | minutes | up to 6 hours |
|
|
|
| Secondary | Duration of Sedation | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the duration of sedation | Posted | Mean | Full Range | minutes | up to 3 hours |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Propofol With Dexmedetomidine (Group DP) | Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. | 0 | 19 | 0 | 19 | 1 | 19 |
|
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| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |