Anesthesia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
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.
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.
DRUGPropofol (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.
Sponsors
Keira Mason
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Ages 7-18 years who are scheduled for upper or lower endoscopic procedures at Boston Children's Hospital and meets criteria to receive dexmedetomidine or propofol sedation for upper and lower endoscopic procedures * Provides written consent to participate in the research study * For females of childbearing age, pregnancy test is negative
Exclusion criteria
* Do not meet established sedation criteria * Refuses administration of study medication prior to sedation * History of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity * Current, repaired or risk of Moya-Moya disease * Recent stroke (cerebrovascular accident) within past 6 months * Uncontrolled hypertension * Concomitant use of opioids, beta antagonist, alpha 2 agonist or calcium channel blocker * Egg, soy or lecithin allergy * BMI greater than 30 or weight above 110th percentile * Refuses insertion of intravenous catheter while awake * Currently receiving pharmacologic agents for hypertension or cardiac disease * Currently receiving or has received digoxin within the past 3 months * Active, uncontrolled gastroesophageal reflux - an aspiration risk * Current (or within past 3 months) history of apnea requiring an apnea monitor * Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction) * Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed * Active, current respiratory issues that are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. | up to 3 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Required to Achieve Sedation | up to 30 minutes | To compare propofol to dexmedetomidine with respect to the time required to receive sedation |
| Time Required to Meet Discharge Criteria From Recovery Room | up to 4 hours | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the time required to meet discharge criteria from recovery room |
| Adverse Events | 3 days | To compare the propofol-only group to dexmedetomidine-propofol group with respect to adverse events |
| Frequency of Adverse Events and the Need for Airway Interventions | 1 day | To compare propofol to dexmedetomidine with respect to the frequency of adverse events and the need for airway interventions |
| Emergence Delirium | up to 4 hours | 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). |
| Time to BIS Score | up to 6 hours | 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 |
| Duration of Sedation | up to 3 hours | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the duration of sedation |
| Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool | up to 3 hours | To compare the propofol-only group to dexmedetomidine-propofol group with respect to the need for unplanned airway interventions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Propofol With Dexmedetomidine (Group DP) | Total | Propofol (Group P) |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 39 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.4 years STANDARD_DEVIATION 3.2 | 13.9 years STANDARD_DEVIATION 3 | 13.2 years STANDARD_DEVIATION 2.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 19 Participants | 34 Participants | 15 Participants |
| Region of Enrollment United States | 20 participants | 39 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 23 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 19 |
| other Total, other adverse events | 0 / 16 | 1 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 |
Outcome results
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.
Time frame: up to 3 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Propofol (Group P) | Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. | 0.4 mg/kg/min |
| Propofol With Dexmedetomidine (Group DP) | Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine. | 0.23 mg/kg/min |
Secondary
Adverse Events
To compare the propofol-only group to dexmedetomidine-propofol group with respect to adverse events
Time frame: 3 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propofol (Group P) | Adverse Events | 0 Participants |
| Propofol With Dexmedetomidine (Group DP) | Adverse Events | 1 Participants |
Secondary
Duration of Sedation
To compare the propofol-only group to dexmedetomidine-propofol group with respect to the duration of sedation
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol (Group P) | Duration of Sedation | 22 minutes |
| Propofol With Dexmedetomidine (Group DP) | Duration of Sedation | 33 minutes |
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).
Time frame: up to 4 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Propofol (Group P) | Emergence Delirium | Score>=10 | 15 Participants |
| Propofol (Group P) | Emergence Delirium | Score<10 | 1 Participants |
| Propofol With Dexmedetomidine (Group DP) | Emergence Delirium | Score>=10 | 18 Participants |
| Propofol With Dexmedetomidine (Group DP) | Emergence Delirium | Score<10 | 1 Participants |
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
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propofol (Group P) | Frequency of Adverse Events and the Need for Airway Interventions | 0 Participants |
| Propofol With Dexmedetomidine (Group DP) | Frequency of Adverse Events and the Need for Airway Interventions | 1 Participants |
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
Time frame: up to 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Propofol (Group P) | Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool | 0 Participants |
| Propofol With Dexmedetomidine (Group DP) | Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool | 1 Participants |
Secondary
Time Required to Achieve Sedation
To compare propofol to dexmedetomidine with respect to the time required to receive sedation
Time frame: up to 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol (Group P) | Time Required to Achieve Sedation | 7.5 minutes |
| Propofol With Dexmedetomidine (Group DP) | Time Required to Achieve Sedation | 7 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
Time frame: up to 4 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol (Group P) | Time Required to Meet Discharge Criteria From Recovery Room | 63 minutes |
| Propofol With Dexmedetomidine (Group DP) | Time Required to Meet Discharge Criteria From Recovery Room | 60 minutes |
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
Time frame: up to 6 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol (Group P) | Time to BIS Score | 45 minutes |
| Propofol With Dexmedetomidine (Group DP) | Time to BIS Score | 50 minutes |