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

NCT02952222 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: P00020516
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Frequency of Adverse Events and the Need for Airway Interventions

  1 day

• Time Required to Achieve Sedation

  up to 30 minutes

• Time Required to Meet Discharge Criteria From Recovery Room

  up to 4 hours

• Adverse Events

  3 days

• Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool

  up to 3 hours

Study Arms (2)

Propofol (Group P)

ACTIVE COMPARATOR

Propofol only

Drug: Propofol (Group P)

Propofol with Dexmedetomidine (Group DP)

ACTIVE COMPARATOR

Propofol with Dexmedetomidine

Drug: Dexmedetomidine; Drug: Propofol (Group DP)

Interventions

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.

Also known as: Precedex

Propofol with Dexmedetomidine (Group DP)

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 P)

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.

Propofol with Dexmedetomidine (Group DP)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Keira Mason: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 33009191 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Keira Mason
• Organization: Boston Children's Hospital

keira.mason@childrens.harvard.edu

(617) 355-7737

Study Officials

• Keira Mason, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: November 2, 2016
• Study Start: May 11, 2018
• Primary Completion: September 11, 2019
• Study Completion: September 12, 2019
• Last Updated: May 10, 2024
• Results First Posted: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)