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Dexmedetomidine for Pediatric Anesthesia
Phase 4
Recruiting
Led By Rahul Baijal, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients age 1 month- 3 years presenting for surgery.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following skin incision
Awards & highlights
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.
Who is the study for?
This trial is for children aged 1 month to 3 years who need surgery. It's not for kids with a history of difficult breathing during anesthesia, metabolic diseases like diabetes, or those on certain meds that affect anesthesia. Also excluded are kids with airway issues, heart problems, obesity, premature birth complications, electrolyte imbalances, GI disease, liver or kidney problems.Check my eligibility
What is being tested?
The study tests how two doses of Dexmedetomidine (0.5mcg/kg and 1mcg/kg) influence the needed amount of Sevoflurane anesthetic in young children undergoing surgery. The goal is to find out if these doses can lower the concentration required safely.See study design
What are the potential side effects?
Dexmedetomidine may cause side effects such as low blood pressure, slow heart rate, dry mouth or nausea. In rare cases it might lead to more serious effects like irregular heartbeat but this will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 1 month and 3 years old and need surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following skin incision
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following skin incision
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Movement
Trial Design
9Treatment groups
Active Control
Placebo Group
Group I: Dexmedetomidine 0.5 mcg/kg 1-6 monthsActive Control1 Intervention
Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group II: Dexmedetomidine 1 mcg/kg 6-12 monthsActive Control1 Intervention
Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group III: Dexmedetomidine 1 mcg/kg 1-3 yearsActive Control1 Intervention
Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group IV: Dexmedetomidine 0.5 mcg/kg 6-12 monthsActive Control1 Intervention
Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group V: Dexmedetomidine 1 mcg/kg 1-6 monthsActive Control1 Intervention
Precedex 1 mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group VI: Dexmedetomidine 0.5 mcg/kg 1-3 yearsActive Control1 Intervention
Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group VII: Placebo 1-6 monthsPlacebo Group1 Intervention
Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group VIII: Placebo 6-12 monthsPlacebo Group1 Intervention
Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Group IX: Placebo 1-3 yearsPlacebo Group1 Intervention
Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,000 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)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an abnormality in my airway.I have irregular heartbeats.I have a gastrointestinal condition.I have a metabolic condition like diabetes.I have lung or chest wall disease but haven't had symptoms worsen in the last 2 weeks.I have liver problems.I was born with a heart condition.I have a condition affecting my brain such as developmental delay, cerebral palsy, or seizures.I or my family have a history of malignant hyperthermia.My baby was born before 37 weeks of pregnancy.I have kidney problems.I am between 1 month and 3 years old and need surgery.I have an imbalance in my body's electrolytes.My BMI is above the 95th percentile for my age.I am taking medication that could affect anesthesia.
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dexmedetomidine 0.5 mcg/kg 1-6 months
- Group 2: Dexmedetomidine 1 mcg/kg 6-12 months
- Group 3: Dexmedetomidine 1 mcg/kg 1-3 years
- Group 4: Placebo 1-6 months
- Group 5: Dexmedetomidine 0.5 mcg/kg 6-12 months
- Group 6: Dexmedetomidine 1 mcg/kg 1-6 months
- Group 7: Dexmedetomidine 0.5 mcg/kg 1-3 years
- Group 8: Placebo 6-12 months
- Group 9: Placebo 1-3 years
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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