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

NCT ID: NCT02952222

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-11
• Study Completion Date: 2019-09-12

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Propofol (Group P)

Propofol only

Group Type: ACTIVE_COMPARATOR

Propofol (Group P)

Intervention Type: 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 with Dexmedetomidine (Group DP)

Propofol with Dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: 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.

Propofol (Group DP)

Intervention Type: 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.

Interventions

Dexmedetomidine

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility 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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keira Mason

OTHER

Sponsor Role: lead

Responsible Party

Keira Mason

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Keira Mason, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33009191 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P00020516

Identifier Type: -

Identifier Source: org_study_id