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

NCT02799589 | Withdrawn Phase 4

• 1 other identifier: Pro00006472
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  90-120 mins (length of surgery)

Secondary Outcomes (4)

• Time to recovery after anesthesia

  10 mins; 1- 4 hours

• Number of patients requiring rescue analgesia in PACU

  30 mins to 4 hours after surgery

• Number of patients with pain after surgery

  1 to 4 hours

• Number of patients with respiratory event

  Anesthesia start to discharge from PACU usually 2- 6 hours

Study Arms (1)

Remifentanil-dexmedetomidine and caudal

EXPERIMENTAL

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

Interventions

Remifentanil DRUG

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

Also known as: Ultiva

Remifentanil-dexmedetomidine and caudal

Dexmedetomidine DRUG

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

Also known as: Precedex

Remifentanil-dexmedetomidine and caudal

Ropivacaine DRUG

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

Also known as: Naropin

Remifentanil-dexmedetomidine and caudal

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 '

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mofya Diallo: lead

MeSH Terms

Interventions

Remifentanil; Dexmedetomidine; Ropivacaine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Mofya Diallo, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 15, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share