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Completed

NCT Number: NCT03422978

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

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.

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Key information

Conditions

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

BC Children's Hospital - Department of Anesthesia

Vancouver, British Columbia, V5Z 4V4, Canada

About this study

Purpose:

To determine an optimal dose of dexmedetomidine for its anesthetic sparing effect, without extending post-operative stay.

Hypothesis:

The investigators hypothesize that dexmedetomidine will cause a clinically significant reduction of 30% in the amount of propofol and remifentanil required to maintain adequate depth of anesthesia, as monitored through the Bispectral Index.

Justification:

The dose-sparing effect of dexmedetomidine on TIVA requirements and the dose-response relationship between dexmedetomidine and TIVA dosing regimens has not been explored in young children. This study will have many relevant applications to many areas of pediatric anesthesia practice, such as craniofacial and neurosurgery, sedation techniques in diagnostic and interventional radiology, out of OR sedation, and in all young children in whom minimizing anesthesia exposure is increasingly sought given possible concerns over the long term neurocognitive effects of surgery and anesthesia in early life.

Objectives:

To investigate the dose-sparing effect on a propofol/remifentanil infusion of bolus doses of dexmedetomidine and to characterize the dose-response relationship between dexmedetomidine doses and TIVA dose reduction.

Research Design:

The investigators propose a randomized, 4-group comparative study to characterize the effects of different bolus doses of dexmedetomidine on the infusion requirements of propofol and remifentanil. The study-specific interventions will include a bolus of dexmedetomidine (or placebo) at induction of anesthesia, and maintenance of anesthesia, titrated to a Bispectral index of 50-60, with propofol and remifentanil infusions.

Statistical Analysis:

Standard statistical analysis will be undertaken using R Foundation for Statistical Computing, Vienna, Austria). Summary data will be tabulated and presented as median (IQR). Mean infusion rates of propofol and remifentanil will be compared between groups using Wilcoxon signed-rank test, with 95% confidence intervals obtained by the Hodges-Lehmann estimator. Dose (in mcg/kg) of additional opioids given in PACU will be tabulated and compared using Fisher's exact test. Bonferroni corrections will be applied as appropriate whenever multiple comparisons are performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine

Drug

Single dose dexmedetomidine administered over 60 seconds post-induction.

Other names: Precedex

normal saline

Drug

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

Primary outcomes

  1. Propofol and remifentanil sparing

    Time frame: Through length of procedure, an average of 1.5 hours

    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.

  2. Propofol and remifentanil infusion rate reduction

    Time frame: Through length of procedure, an average of 1.5 hours

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

Secondary outcomes

  1. PACU sedation

    Time frame: 30min post-procedure

    Sedation will be scored from 0 (alert) to 4 (unarousable) using the University of Michigan sedation score (UMSS) at 10, 20, and 30 minutes post discontinuation of the infusions.

  2. PACU pain scores

    Time frame: 30min post-procedure

    Pain will be scored from 0 (no pain) to 10 (severe pain), using the FLACC pain scale for ages 2-7 and the FACES pain scale for ages 8-10, and total fentanyl doses in mcg/kg given in the Post Anesthetic Care Unit will be recorded.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Anesthetic Sparing Effect of Dexmedetomidine During TIVA With Propofol and Remifentanil for Children Undergoing Dental Procedures

Acronym: Dexmed-PRS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2018
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.