Methadone Anesthesia For Kidney Transplant Receptors

Intraoperative Use Of Methadone In The Prevention of Postoperative Pain in Kidney Transplant Receptors

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

Study Overview

• Status: Recruiting
• Conditions: Surgery; Renal Failure Chronic
• Intervention / Treatment: Drug: Methadone; Drug: Fentanyl

Detailed Description

Despite recent developments in postoperative pain control, many patients still experience moderate or severe pain after surgery. It is estimated that severe postoperative pain occurs in 20 to 40% of surgical procedures. With the development of kidney transplant services, a better study of the intraoperative analgesia used in this procedure and its impact on the postoperative is necessary. The management of postoperative pain in renal transplant recipients is essential to improve the quality of postoperative care, and may even impact the prognosis of the renal graft. One of the strategies to improve pain control in the perioperative period is the intraoperative use of intravenous methadone, given its pharmacokinetic profile. Methadone is an opioid agonist of µ receptors, it is also a Glutamate antagonist by blocking the N-methyl-D-aspartate (NMDA) receptor, and inhibits the reuptake of serotonin and norepinephrine. When administered in doses of 20 to 30mg, the analgesia generated by methadone can last from 24 to 36 hours. There is also evidence that the use of methadone in doses of 0.2 to 0.3 mg / kg is not associated with a higher incidence of side effects when compared to other opioids with short or intermediate duration of action, such as fentanyl, sufentanil and morphine. The aim of this study is to evaluate the effectiveness of using intraoperative methadone to reduce postoperative pain in patients undergoing kidney transplant surgery (recipients). Patients will be submitted to standardized general anesthesia, and the opioid used in anesthetic induction will be methadone or fentanyl with additional boluses if necessary. After extubation, Fentanyl will be installed in an intravenous analgesia pump controlled by the patient. Differences between groups regarding opioid consumption, pain scores, side effects and patient satisfaction will be assessed

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Felipe C Machado, MD, PhD; Phone Number: 6335 +551126616335; Email: felipe.chiodini@hc.fm.usp.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Recruiting
      • Hospital das Clínicas da FMUSP
      • Contact: Felipe Machado, MD; Phone Number: +551126617947; Email: felipe.chiodini@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methadone; Methadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery	Drug: Methadone; Used at induction and during surgery
Active Comparator: Fentanyl; Fentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery	Drug: Fentanyl; Used at induction and during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid-related side effects 24h postoperatively	Opioid-related side effects	One day after surgery
Opioid-related side effects 48h postoperatively	Opioid-related side effects	Two days after surgery
Opioid-related side effects 72h postoperatively	Opioid-related side effects	Three days after surgery

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Felipe C Machado, MD, PhD, USP

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Respiratory System Agents; Antitussive Agents; Fentanyl; Methadone
• Other Study ID Numbers: MEFERENAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No