Methadone Anesthesia For Kidney Transplant Receptors

NCT04908345 | Unknown Phase 3 DMC

• 1 other identifier: MEFERENAL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative methadone or fentanyl will be administered to patients submitted to kidney transplant surgery. Postoperative pain, analgesic consumption and side effects will be evaluated

Conditions

Renal Failure Chronic; Surgery

Outcome Measures

Primary Outcomes (6)

• Pain score 24h postoperatively

  Reported pain in a scale of 0 (no pain) to 10 (maximum pain)

  One day after surgery

• Pain score 48h postoperatively

  Reported pain in a scale of 0 (no pain) to 10 (maximum pain)

  Two days after surgery

• Pain score 72h postoperatively

  Reported pain in a scale of 0 (no pain) to 10 (maximum pain)

  Three days after surgery

• Analgesic use 24h postoperatively

  Analgesic use after surgery

  One day after surgery

• Analgesic use 48h postoperatively

  Analgesic use after surgery

  Two days after surgery

• Analgesic use 72h postoperatively

  Analgesic use after surgery

  Three days after surgery

Secondary Outcomes (3)

• Opioid-related side effects 24h postoperatively

  One day after surgery

• Opioid-related side effects 48h postoperatively

  Two days after surgery

• Opioid-related side effects 72h postoperatively

  Three days after surgery

Study Arms (2)

Methadone

EXPERIMENTAL

Methadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery

Drug: Methadone

Fentanyl

ACTIVE COMPARATOR

Fentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery

Drug: Fentanyl

Interventions

Methadone DRUG

Used at induction and during surgery

Methadone

Fentanyl DRUG

Used at induction and during surgery

Fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• With indication for kidney transplant surgery
• Who sign the informed consent form

You may not qualify if:

• Patients who refuse to participate in the study
• Known allergy to any drug used in this protocol
• Presence of stage III or IV congestive heart failure
• Increase in QT interval on electrocardiogram (QT\> 500 msec)
• Preemptive kidney transplantation (defined by transplantation in a patient who has not yet started kidney replacement therapy).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Methadone; Fentanyl

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Felipe C Machado, MD, PhD

  USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felipe C Machado, MD, PhD

CONTACT

+551126616335; felipe.chiodini@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Methadone x Fentanyl

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 1, 2021
• Study Start: May 17, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)