Anesthetic SparingPhase 4Dexmed-PRSNCT03422978
The Effects of Dexmedetomidine on Intravenous Anesthetic Requirements for Children Undergoing Dental Procedures
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Anesthetic Sparing, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Anesthetic Sparing
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2018to 1 Apr 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA 1-2
- Elective dental surgery
- Planned general anesthesia with TIVA
- Age 2-10 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, V5Z 4V4
About this study
Official title: Anesthetic Sparing Effect of Dexmedetomidine During TIVA With Propofol and Remifentanil 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.
Read the 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.
- Conditions
- Anesthetic Sparing
- Being tested
- Dexmedetomidine, Normal saline
- Keywords
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Single dose dexmedetomidine administered over 60 seconds post-induction.
Normal salineDrug
Single dose normal saline administered over 60 seconds post-induction.
| Study group | Role | What they receive |
|---|---|---|
| Saline bolus | Sham comparator | 10mL normal saline solution administered intravenously over 60 seconds starting after intubation. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through length of procedure, an average of 1.5 hours
Secondary outcomes (2)
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.
Measured: 30min post-procedure
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.
Measured: 30min post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start14 Mar 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthetic SparingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Whyte, University of British Columbia
- Investigators
- Simon Whyte, MBBS, FRCA, Principal investigator, BC Children's Hospital, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422978
- Sponsor's protocol ID
- H17-02157
- Acronym
- Dexmed-PRS
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2017
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39193655
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Sparing Effect of Dexmedetomidine During TIVA With Propofol and Remifentanil for Children Undergoing Dental Procedures
- ClinicalTrials.gov ID
- NCT03422978
- Acronym / sponsor ID
- Dexmed-PRS / H17-02157
- Conditions
- Anesthetic Sparing
- Keywords
- Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline bolus | Sham comparator | Drug: Normal saline10mL normal saline solution administered intravenously over 60 seconds starting after intubation. |
| Dexmedetomidine 0.25 mcg/kg | Experimental | Drug: Dexmedetomidine0.25 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation. |
| Dexmedetomidine 0.50 mcg/kg | Experimental | Drug: Dexmedetomidine0.50 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation. |
| Dexmedetomidine 1.00 mcg/kg | Experimental | Drug: Dexmedetomidine1.00 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA 1-2
- Elective dental surgery
- Planned general anesthesia with TIVA
- Age 2-10 years
Key exclusion criteria (8 listed)
- General anesthesia with inhalation induction
- Documented seizure disorder
- Cardiac disease
- Cardiac rhythm abnormalities
- Chronic hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexSingle dose dexmedetomidine administered over 60 seconds post-induction. | Drug | Dexmedetomidine 0.25 mcg/kg, Dexmedetomidine 0.50 mcg/kg, Dexmedetomidine 1.00 mcg/kg |
| Normal salineSingle dose normal saline administered over 60 seconds post-induction. | Drug | Saline bolus |
Primary outcome
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.
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.
2 secondary outcomes
PACU sedation
Time frame: 30min post-procedure
PACU pain scores
Time frame: 30min post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 39193655Lee 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.
- Pediatric Anesthesia Research Team websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Whyte, MBBS, FRCA principal investigator
BC Children's Hospital, Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Anesthetic Sparing, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol and remifentanil sparing (time frame: Through length of procedure, an average of 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.