A Phase 4 interventional study of Remifentanil and Dexmedetomidine in Anesthesia, sponsored by Mofya Diallo. Withdrawn. Open to participants aged 1 Year to 3 Years. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by Mofya Diallo · Phase 4, Interventional, and Treatment
This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in combination with a caudal block for patients ages 1 year to 3 years old receiving elective surgery to investigate alternatives to the currently used volatile anesthetics.
In light of the concern for potential anesthetic neurotoxicity in infants and toddlers, it is prudent to start investigating alternative methods to decrease the amount of volatile anesthetic being utilized in this patient population. The US Food and Drug Administration has been asked to evaluate the data showing the neurotoxic effects of multiple anesthetic agents in animal models and humans. These studies have shown that N-methyl-D-aspartate (NMDA) receptor blockers such as ketamine,and gamma-Aminobutyric acid receptor (GABA) modulators like benzodiazepines, nitrous, propofol, barbiturates and isoflurane have been shown to cause brain cell apoptosis in animal models.
Regional anesthesia provides both intraoperative and postoperative analgesia may play a major role in effectively reducing the amount of general anesthetic used. Caudal anesthesia has been proven be both safe, effective and is applied widely in the pediatric population.
Dexmedetomidine is a selective alpha2-adrenergic agonist that acts in the brainstem by inhibiting norepinephrine release. Dexmedetomidine is commonly used off-label, including use for duration greater than 24 hours and any use in pediatrics. Dexmedetomidine has relatively few adverse events when compared to other sedative agents, with hypotension and bradycardia being most common.
Remifentanil has a rapid onset, rapid offset, small volume of distribution, rapid clearance, and a short elimination half-life, It may be a useful anesthetic for pediatric outpatient surgery.
While the current standard of care involves a volatile general anesthetic with a caudal block, anesthesiologists have alternative methods that can be utilized to allow an elective surgery to be performed. In summary, this study intends to show the efficacy and safety of a remifentanil-dexmedetomidine infusion and caudal block for patients ages 1 year-3 years old receiving elective circumcision, hydrocele repair, orchidopexy, mild hypospadias or inguinal hernia repair. This alternative anesthetic is already being studied in children under 12 months.
This is the only study on the registry with Mofya Diallo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anesthesia will be induced with inhaled sevoflurane which will be discontinued once IV access is obtained and the airway is secured with an endotracheal tube. Patients will receive remifentanil loading dose of 1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min) and dexmedetomidine load at 1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr) A caudal block with 0.2% ropivacaine will be performed in all patients for intraoperative and postoperative pain control.
Drug: Remifentanil · Drug: Dexmedetomidine · Drug: Ropivacaine
1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min)
Also known as: Ultiva
1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr)
Also known as: Precedex
Caudal anesthesia block with Ropivicaine 0.2% 1ml/kg injected into the caudal space
Also known as: Naropin
Number of patients requiring intervention for light anesthesia
Identified by patient movement, change in mean arterial pressure \>80 at surgical incision, need to change anesthetic plan
Time frame: 90-120 mins (length of surgery)
Time to recovery after anesthesia
Time from end of surgery to: extubation; time to discharge from post-anesthesia care unit (PACU)
Time frame: 10 mins; 1- 4 hours
Number of patients requiring rescue analgesia in PACU
Use of Fentanyl, Morphine, Ketorolac in recovery unit,
Time frame: 30 mins to 4 hours after surgery
Number of patients with pain after surgery
Pain is assessed after recovery on Face, Legs, Activity, Cry, Consolability (FLACC) scale 0 to 10. Average score will be noted.
Time frame: 1 to 4 hours
Number of patients with respiratory event
Bronchospasm, laryngospasm and pulse oximetry desaturation to less than 90%
Time frame: Anesthesia start to discharge from PACU usually 2- 6 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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