Remifentanil-dexmedetomidine Anesthesia With a Caudal for Elective Surgery. (Remi-dex)

NCT ID: NCT02799589

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remifentanil-dexmedetomidine and caudal

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.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min)

Dexmedetomidine

Intervention Type: DRUG

1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr)

Ropivacaine

Intervention Type: DRUG

Caudal anesthesia block with Ropivicaine 0.2% 1ml/kg injected into the caudal space

Interventions

Remifentanil

1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min)

Intervention Type: DRUG

Dexmedetomidine

1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr)

Intervention Type: DRUG

Ropivacaine

Caudal anesthesia block with Ropivicaine 0.2% 1ml/kg injected into the caudal space

Intervention Type: DRUG

Other Intervention Names

Ultiva; Precedex; Naropin

Eligibility Criteria

Inclusion Criteria

• Children aged 1 - 3 years undergoing urologic surgery (circumcision, hydrocele repair, orchidopexy, mild hypospadias) or inguinal hernia repair
• American Society of Anesthesiologist Physical Status (ASA-PS) I or II
• Eligible for caudal block
• Parental/legal guardian consents for study '

Exclusion Criteria

• Allergy to remifentanil, dexmedetomidine or ropivacaine
• Family history of malignant hyperthermia
• Parental/legal guardian refusal
• ASA-PS ≥ 3
• Symptoms of upper respiratory infection (URI) within the 2 weeks prior to surgery
• Known spinal deformity, presence of sacral dimple, or signs of infection at the site of the caudal block (e.g. diaper rash, skin redness or tenderness).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mofya Diallo

OTHER

Sponsor Role: lead

Responsible Party

Mofya Diallo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mofya Diallo, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Other Identifiers

Pro00006472

Identifier Type: -

Identifier Source: org_study_id