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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03422978
Acronym
Dexmed-PRS
Enrollment
88
Registered
2018-02-06
Start date
2018-03-14
Completion date
2021-04-01
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthetic Sparing

Keywords

Dexmedetomidine

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.

Detailed description

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.

Interventions

DRUGDexmedetomidine

Single dose dexmedetomidine administered over 60 seconds post-induction.

DRUGNormal saline

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

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

Assessor of sedation scores post-procedure will be blinded to group allocation.

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Propofol and remifentanil sparingThrough length of procedure, an average of 1.5 hoursPropofol and remifentanil sparing as measured by time-averaged, total administered doses of propofol (mg/kg) and remifentanil (mcg/kg) compared to the placebo group.
Propofol and remifentanil infusion rate reductionThrough length of procedure, an average of 1.5 hoursChange in infusion rates of propofol and remifentanil (in micrograms/kg/min), measured over time compared to the placebo group.

Secondary

MeasureTime frameDescription
PACU sedation30min post-procedureSedation 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.
PACU pain scores30min post-procedurePain 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026