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

Anesthetic Sparing Clinical Trial

— Dexmed-PRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422978
• Other study ID #: H17-02157
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthetic Sparing

Intervention

Drug:
• Dexmedetomidine
Single dose dexmedetomidine administered over 60 seconds post-induction.
• Normal saline
Single dose normal saline administered over 60 seconds post-induction.

Locations

Country	Name	City	State
Canada	BC Children's Hospital - Department of Anesthesia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PACU sedation	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.	30min post-procedure
Secondary	PACU pain scores	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.	30min post-procedure

External Links

•   Pediatric Anesthesia Research Team website