Dexmedetomidine 0.5 mcg/kg 1-6 months for Pediatric Anesthesia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Texas Children's Hospital, Houston, TXPediatric AnesthesiaDexmedetomidine - Drug
Eligibility
1 - 36
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether lower doses of the drug Dexmedetomidine can achieve the same effect as a higher dose of the drug, when used in combination with Sevoflurane, in children aged 1-3 years old.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Immediately following skin incision

Immediately following skin incision
Movement

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

9 Treatment Groups

Dexmedetomidine 0.5 mcg/kg 1-6 months
1 of 9
Dexmedetomidine 1 mcg/kg 6-12 months
1 of 9
Dexmedetomidine 1 mcg/kg 1-3 years
1 of 9
Dexmedetomidine 0.5 mcg/kg 6-12 months
1 of 9
Dexmedetomidine 1 mcg/kg 1-6 months
1 of 9
Dexmedetomidine 0.5 mcg/kg 1-3 years
1 of 9
Placebo 1-6 months
1 of 9
Placebo 6-12 months
1 of 9
Placebo 1-3 years
1 of 9

Active Control

Non-Treatment Group

180 Total Participants · 9 Treatment Groups

Primary Treatment: Dexmedetomidine 0.5 mcg/kg 1-6 months · Has Placebo Group · Phase 4

Placebo 1-6 months
Drug
PlaceboComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Dexmedetomidine 0.5 mcg/kg 1-6 months
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Dexmedetomidine 1 mcg/kg 6-12 months
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Dexmedetomidine 1 mcg/kg 1-3 years
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Dexmedetomidine 0.5 mcg/kg 6-12 months
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Dexmedetomidine 1 mcg/kg 1-6 months
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Dexmedetomidine 0.5 mcg/kg 1-3 years
Drug
ActiveComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Placebo 6-12 months
Drug
PlaceboComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug
Placebo 1-3 years
Drug
PlaceboComparator Group · 1 Intervention: Dexmedetomidine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately following skin incision

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
931 Previous Clinical Trials
5,989,135 Total Patients Enrolled
Rahul Baijal, MDPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
Tulane University School Of Medicine (Medical School)
Johns Hopkins University School Medicine (Residency)

Eligibility Criteria

Age 1 - 36 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Could you provide a list of recent trials assessing the efficacy of Dexmedetomidine 0.5 mcg/kg over 1-6 months?

"Currently, 110 clinical trials encompassing Dexmedetomidine 0.5 mcg/kg 1-6 months are underway with 23 of those in the third phase. While mainly based out of Karachi, Sindh, 207 medical centres globally have research for this medication ongoing." - Anonymous Online Contributor

Unverified Answer

Are there any age restrictions for recruitment in this clinical trial?

"This research is open to all participants between 1 and 36 months of age." - Anonymous Online Contributor

Unverified Answer

Does my medical profile qualify me to take part in the experiment?

"Requirements for entry into this clinical trial are anesthesia, pediatric age range between 1 month and 36 months. Approximately 180 individuals must be recruited to participate in the experiment." - Anonymous Online Contributor

Unverified Answer

What is the standard use of Dexmedetomidine 0.5 mcg/kg 1-6 months?

"Dexmedetomidine 0.5 mcg/kg 1-6 months is a widely used therapy to treat this disease as well as additional ailments such as ventilations, mechanical, cyclic vomiting syndrome and intubations." - Anonymous Online Contributor

Unverified Answer

To what extent is enrollment in this clinical trial being pursued?

"Correct. According to the information hosted on clinicaltrials.gov, this trial is presently seeking participants and was first posted on February 18th 2018. To complete this study, 180 patients need to be enrolled from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies currently available for participants of this clinical trial?

"Affirmative. Clinicaltrials.gov has records of this clinical trial beginning its recruitment process on February 18th 2018 and was last updated March 29th 2022, with the aim to recruit 180 patients from one location." - Anonymous Online Contributor

Unverified Answer

What potential risks does Dexmedetomidine 0.5 mcg/kg 1-6 months pose to individuals?

"The safety rating of Dexmedetomidine 0.5 mcg/kg 1-6 months was determined to be 3, since this is a Phase 4 trial and the associated medication has been approved." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.