The Effects of Dexmedetomidine on Intravenous Anesthetic Requirements for Children Undergoing Dental Procedures

NCT03422978 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: H17-02157
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to determine the propofol and remifentanil sparing effects of a single dose of dexmedetomidine in the dental population. The investigators plan to do this by performing a blinded study with 4 test groups (3 experimental and 1 control), using BIS monitoring to titrate TIVA infusion to an acceptable depth of anesthesia.

Conditions

Anesthetic Sparing

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• Propofol and remifentanil sparing

  Propofol and remifentanil sparing as measured by time-averaged, total administered doses of propofol (mg/kg) and remifentanil (mcg/kg) compared to the placebo group.

  Through length of procedure, an average of 1.5 hours

• Propofol and remifentanil infusion rate reduction

  Change in infusion rates of propofol and remifentanil (in micrograms/kg/min), measured over time compared to the placebo group.

  Through length of procedure, an average of 1.5 hours

Secondary Outcomes (2)

• PACU sedation

  30min post-procedure

• PACU pain scores

  30min post-procedure

Study Arms (4)

Saline bolus

SHAM COMPARATOR

10mL normal saline solution administered intravenously over 60 seconds starting after intubation.

Drug: Normal saline

Dexmedetomidine 0.25 mcg/kg

EXPERIMENTAL

0.25 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.

Drug: Dexmedetomidine

Dexmedetomidine 0.50 mcg/kg

EXPERIMENTAL

0.50 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.

Drug: Dexmedetomidine

Dexmedetomidine 1.00 mcg/kg

EXPERIMENTAL

1.00 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Single dose dexmedetomidine administered over 60 seconds post-induction.

Also known as: Precedex

Dexmedetomidine 0.25 mcg/kg; Dexmedetomidine 0.50 mcg/kg; Dexmedetomidine 1.00 mcg/kg

Normal saline DRUG

Single dose normal saline administered over 60 seconds post-induction.

Saline bolus

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1-2
• Elective dental surgery
• Planned general anesthesia with TIVA
• Age 2-10 years

You may not qualify if:

• General anesthesia with inhalation induction
• Documented seizure disorder
• Cardiac disease
• Cardiac rhythm abnormalities
• Chronic hypertension
• Weight \< 5th centile or \> 95th centile for age
• Pre-operative administration of anxiolytics (such as benzodiazepines or opioid analgesics)
• Hypersensitivity to dexmedetomidine or any other study medication

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital - Department of Anesthesia

Vancouver, British Columbia, V5Z 4V4, Canada

Location

Related Publications (1)

• Lee VCL, Ridgway R, West NC, Gorges M, Whyte SD. Anesthetic-sparing effect of dexmedetomidine during total intravenous anesthesia for children undergoing dental surgery: A randomized controlled trial. Paediatr Anaesth. 2024 Dec;34(12):1213-1222. doi: 10.1111/pan.14987. Epub 2024 Aug 28.

  PMID: 39193655 DERIVED

Related Links

• Pediatric Anesthesia Research Team website

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Simon Whyte, MBBS, FRCA

  BC Children's Hospital, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor of sedation scores post-procedure will be blinded to group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: February 6, 2018
• Study Start: March 14, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)