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The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy

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ClinicalTrials.gov Identifier: NCT02952222
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Keira Mason, Boston Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Dexmedetomidine Drug: Propofol (Group P) Drug: Propofol (Group DP) Phase 4

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: Propofol (Group P)
Propofol only
Drug: 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.

Active Comparator: Propofol with Dexmedetomidine (Group DP)
Propofol with Dexmedetomidine
Drug: 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.
Other Name: Precedex

Drug: 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.




Primary Outcome Measures :
  1. Propofol requirements with pre-treatment of dexmedetomidine with children who do not receive dexmedetomidine. [ Time Frame: 2 years ]
    Compare the total propofol requirements (in mg/kg) of children who receive intravenous propofol with pre-treatment of dexmedetomidine with the propofol requirements in children who do not receive dexmedetomidine.


Secondary Outcome Measures :
  1. Frequency of adverse events and the need for airway interventions [ Time Frame: 2 years ]
    To compare propofol to dexmedetomidine with respect to the frequency of adverse events and the need for airway interventions

  2. Time required to achieve sedation [ Time Frame: 2 years ]
    To compare propofol to dexmedetomidine with respect to the time required to receive sedation

  3. Amount of sedative medications administered other than propofol or dexmedetomidine [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect for supplemental sedation during the study

  4. Time required to meet discharge criteria from recovery room [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect to the time required to meet discharge criteria from recovery room

  5. Adverse events [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect to adverse events

  6. Number of unplanned airway interventions according to the World SIVA adverse sedation event reporting tool [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect to the need for unplanned airway interventions

  7. Emergence Delirium [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect to the PAED score

  8. BIS score [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect to the return of BIS score to baseline (pre-sedation level) in recovery room

  9. Duration of Sedation [ Time Frame: 2 years ]
    To compare the propofol-only group to dexmedetomidine-propofol group with respect to the duration of sedation



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952222


Contacts
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Contact: Erin Halpin, MSN 857-218-4585 erin.halpin@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Erin Halpin    857-218-4585      
Sponsors and Collaborators
Keira Mason
Investigators
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Principal Investigator: Keira Mason, MD Boston Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Keira Mason, MD, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02952222    
Other Study ID Numbers: P00020516
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action