Dexmedetomidine for Pediatric Anesthesia
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Baylor College of Medicine
Must not be taking: Anticonvulsants, Opioids, Benzodiazepines, others
Disqualifiers: Lung disease, Heart disease, Obesity, others
Prior Safety Data
Approved in 4 Jurisdictions
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.
12345Is 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.
13467How 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.
12358Eligibility 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.
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Trial 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
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Children's HospitalHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
References
Dexmedetomidine use in pediatric airway reconstruction. [2022]Assess the postoperative use of dexmedetomidine (Precedex) in pediatric patients following airway reconstruction.
Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. [2013]Dexmedetomidine (Precedex is an alpha2 adrenoceptor agonist which is gaining popularity as a sedative and anesthetic adjuvant. In this case report, dexmedetomidine was used safely and easily to provide sedation for 12 radiation-therapy sessions in a pediatric patient. It provided smooth induction and fast recovery with minimal respiratory depression.
Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 μg/kg load; 0.05-0.2 μg/kg/h infusion); those aged 1 month to <17 years received dose level 2 (1 μg/kg load; 0.2-2.0 μg/kg/h infusion). Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90); of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3); change in medical condition (need for intubation) requiring deeper level of sedation (n = 2); adverse event (AE; hives and emesis), lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each). Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline) and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2 dropped by 10% in two patients, but resolved without need for manual ventilation. All other reported AEs were consistent with the known safety profile of dexmedetomidine. Two of the 78 patients in the efficacy-evaluable population met all sedation efficacy criteria. Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation.
Effect of dexmedetomidine on preventing perioperative respiratory adverse events in children: A systematic review and meta‑analysis of randomized controlled trials. [2023]The most common critical incidents in pediatric anesthesia are perioperative respiratory adverse events (PRAEs). The present meta-analysis aimed to assess the preventive effect of dexmedetomidine on PRAEs in children. Dexmedetomidine is a highly selective α2-adrenoceptor agonist that provides sedation, anxiolysis and analgesic effects without causing respiratory depression. Dexmedetomidine can diminish airway and circulatory responses during extubation in children. Original randomized controlled trial data were analyzed to study the putative effect of dexmedetomidine on PRAEs. By searched the Cochrane Library, EMBASE and PubMed, a total of ten randomized controlled trials (1,056 patients) was identified. PRAEs included cough, breath holding, laryngospasm, bronchospasm, desaturation (percutaneous oxygen saturation <95%), body movement and pulmonary rales. Compared with placebo, dexmedetomidine resulted in a significant reduction of incidence of cough, breath holding, laryngospasm and emergence agitation. The incidence of PRAEs was significantly reduced in dexmedetomidine compared with active comparators group. Moreover, dexmedetomidine decreased heart rate and increased post-anesthesia care unit stay duration by 11.18 min. The present analysis suggested that dexmedetomidine improved the airway function and decreased risks associated with general anesthesia in children. The present data demonstrated that dexmedetomidine may be a good choice to prevent PRAEs in children.
Dexmedetomidine-related atrial standstill and loss of capture in a pediatric patient after congenital heart surgery. [2013]Dexmedetomidine (DEX; Precedex) is an alpha-2 adrenergic receptor agonist that produces anxiolysis and sleep-like sedation without narcosis or respiratory depression and has relatively few cardiovascular side effects. Given its favorable sedative properties combined with its limited effects on hemodynamic and respiratory function, it is widely used in pediatric intensive care and anesthesia settings.
Dexmedetomidine use in pediatric intensive care and procedural sedation. [2022]Dexmedetomidine was approved by the Food and Drug Administration in 1999 for the sedation of adults receiving mechanical ventilation in an intensive care setting. It provides sedation with minimal effects on respiratory function and may be used prior to, during, and following extubation. Based on its efficacy in adults, dexmedetomidine is now being explored as an alternative or adjunct to benzodiazepines and opioids in the pediatric intensive care setting. This review describes the studies evaluating the safety and efficacy dexmedetomidine in infants and children and provides recommendations on dosing and monitoring.
Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. [2017]Dexmedetomidine (DEX) is widely used in pediatric procedural sedation (PPS) by a variety of pediatric subspecialists. The objective of our study was to describe the overall rates of adverse events and serious adverse events (SAEs) when DEX is used by various pediatric subspecialists.
[Feasibility and Safety of Dexmedetomidine Sedation in Transarterial Embolization for Hepatocellular Carcinoma with Hepatitis C-Related Cirrhosis]. [2015]Dexmedetomidine (Precedex®)is an agonist of a2-adrenergic receptors in certain parts of the brain. It was approved for "procedural sedation in the non-intubation in under local anesthesia" in June 2013 in Japan. However, because of metabolism delay, dexmedetomidine has to be administered carefully to patients with liver dysfunction.