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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-14

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation

NCT03255824

Anesthesia

COMPLETED PHASE4

Dexmedetomidine Sedation With Third Molar Surgery

NCT01017237

Anesthesia

TERMINATED PHASE4

Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

NCT04509414

Deep Sedation Dexmedetomidine

COMPLETED PHASE4

Dexmetomidine in Children Undergoing General Anaesthesia

NCT03923075

Anesthesia

COMPLETED NA

The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children

NCT02353169

Myocardial Repolarization Healthy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthetic Sparing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saline bolus

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

Group Type SHAM_COMPARATOR

Normal saline

Intervention Type DRUG

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

Dexmedetomidine 0.25 mcg/kg

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Single dose dexmedetomidine administered over 60 seconds post-induction.

Dexmedetomidine 0.50 mcg/kg

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Single dose dexmedetomidine administered over 60 seconds post-induction.

Dexmedetomidine 1.00 mcg/kg

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Single dose dexmedetomidine administered over 60 seconds post-induction.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

Single dose dexmedetomidine administered over 60 seconds post-induction.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No