Dexmedetomidine for Pediatric Anesthesia

Overseen By Margaret Owens-Stuberfield

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Must not be taking: Anticonvulsants, Opioids, Benzodiazepines, others

Disqualifiers: Lung disease, Heart disease, Obesity, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Single session

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two different amounts of a sedative drug called Dexmedetomidine in young children. The goal is to see if it reduces the amount of another anesthetic, Sevoflurane, needed during surgery. Dexmedetomidine helps calm the patient and reduces stress, which means less Sevoflurane is required. Dexmedetomidine has been studied extensively for its sedative effects in children, showing benefits in reducing the required dose of other anesthetics like Sevoflurane.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications like anticonvulsants, opioids, benzodiazepines, antibiotics, and antihistamines, as they can affect the study's results.

What data supports the effectiveness of the drug Dexmedetomidine for pediatric anesthesia?

Research shows that Dexmedetomidine is effective in providing sedation for children during procedures, reducing the risk of breathing problems and other complications associated with anesthesia. It helps keep children calm and comfortable without causing significant breathing issues, making it a good choice for pediatric anesthesia. ^{1 2 3 4 5}

Is dexmedetomidine safe for use in children?

Dexmedetomidine, also known as Precedex, has been studied for safety in children undergoing sedation for procedures. Common side effects include respiratory depression (slowed breathing) and hypotension (low blood pressure), but it is generally well-tolerated. It can also help reduce breathing problems during anesthesia in children. ^{1 3 4 6 7}

How is the drug Dexmedetomidine unique for pediatric anesthesia?

Dexmedetomidine is unique for pediatric anesthesia because it allows children to maintain spontaneous breathing without the need for a breathing tube, providing sedation with minimal respiratory depression. It is an alpha-2 adrenergic receptor agonist, which means it works by calming certain parts of the brain, and is known for smooth induction and fast recovery. ^{1 2 3 5 8}

Research Team

Rahul Baijal, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I am between 1 month and 3 years old and need surgery.

Exclusion Criteria

I have an abnormality in my airway.

I have irregular heartbeats.

I have a gastrointestinal condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dexmedetomidine or placebo intravenously prior to surgical procedure to assess its effect on the minimum alveolar concentration of Sevoflurane

Single session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dexmedetomidine

Trial Overview 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.

Participant Groups

Group I: Dexmedetomidine 0.5 mcg/kg 1-6 months Active Control 1 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 months Active Control 1 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 years Active Control 1 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 months Active Control 1 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 months Active Control 1 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 years Active Control 1 Intervention

Precedex 0.5mcg/kg intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group VII: Placebo 1-6 months Placebo Group 1 Intervention

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group VIII: Placebo 6-12 months Placebo Group 1 Intervention

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Group IX: Placebo 1-3 years Placebo Group 1 Intervention

Saline intravenous administered over 10 minutes prior to surgical procedure. Assigned sevoflurane concentration.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Findings from Research

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

Dexmedetomidine was safely used to sedate a pediatric patient during 12 radiation therapy sessions, demonstrating its effectiveness as a sedative and anesthetic adjuvant.

The use of dexmedetomidine resulted in smooth induction and quick recovery while causing minimal respiratory depression, highlighting its favorable safety profile in pediatric sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. Shukry, M., Ramadhyani, U.[2013]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

Dexmedetomidine significantly reduces the incidence of perioperative respiratory adverse events (PRAEs) such as cough, breath holding, and laryngospasm in children, based on a meta-analysis of 10 randomized controlled trials involving 1,056 patients.

In addition to lowering the risk of PRAEs, dexmedetomidine also decreases heart rate and extends post-anesthesia care unit stay by about 11 minutes, indicating its potential to improve airway function and safety during pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexmedetomidine on preventing perioperative respiratory adverse events in children: A systematic review and meta‑analysis of randomized controlled trials. Zhang, J., Yin, J., Li, Y., et al.[2023]

Dexmedetomidine (DEX) is an effective sedative that provides anxiolysis and sedation without causing respiratory depression, making it suitable for use in pediatric intensive care.

In a case involving a three-year-old girl with a pacemaker, DEX administration led to unsuccessful atrial capture, suggesting that caution is needed when using DEX in patients with existing conduction abnormalities or those who are pacemaker-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. Shepard, SM., Tejman-Yarden, S., Khanna, S., et al.[2013]

Dexmedetomidine is a promising sedative for children in intensive care, showing efficacy in reducing the need for other sedatives and being particularly beneficial for those with neurologic impairments.

While generally well tolerated, dexmedetomidine can cause hypotension and bradycardia in 10% to 20% of patients, necessitating careful monitoring during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric intensive care and procedural sedation. Buck, ML.[2022]

In a study of 13,072 children undergoing pediatric procedural sedation with dexmedetomidine (DEX), the overall adverse event rate was low at 3.6%, with serious adverse events (SAEs) occurring in only 0.34% of cases, indicating a high safety profile for DEX in this setting.

The most common serious adverse event was airway obstruction, which occurred in 0.27% of patients, while the sedation success rate was exceptionally high at 99.7%, demonstrating DEX's efficacy in pediatric procedural sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Sulton, C., McCracken, C., Simon, HK., et al.[2017]

In a study of 30 patients with liver dysfunction undergoing percutaneous arterial chemoembolization for hepatocellular carcinoma, dexmedetomidine sedation was successfully used in all cases, demonstrating its feasibility for this procedure.

The sedation was generally safe, with only minor adverse events reported in 3 patients, and no serious complications requiring treatment, indicating that dexmedetomidine can be a reliable option for sedation in patients with liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. Komemushi, A., Suzuki, S., Sano, A., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. [2013]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]

4. Greece pubmed.ncbi.nlm.nih.gov

Effect of dexmedetomidine on preventing perioperative respiratory adverse events in children: A systematic review and meta‑analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric intensive care and procedural sedation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. [2017]

8. Japan pubmed.ncbi.nlm.nih.gov

[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. [2015]