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Methadone Anesthesia For Kidney Transplant Receptors

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04908345
Enrollment
32
Registered
2021-06-01
Start date
2021-05-17
Completion date
2022-01-31
Last updated
2021-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure Chronic, Surgery

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

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

Interventions

DRUGMethadone

Used at induction and during surgery

DRUGFentanyl

Used at induction and during surgery

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Methadone x Fentanyl

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Analgesic use 72h postoperativelyThree days after surgeryAnalgesic use after surgery
Pain score 72h postoperativelyThree days after surgeryReported pain in a scale of 0 (no pain) to 10 (maximum pain)
Analgesic use 24h postoperativelyOne day after surgeryAnalgesic use after surgery
Analgesic use 48h postoperativelyTwo days after surgeryAnalgesic use after surgery
Pain score 24h postoperativelyOne day after surgeryReported pain in a scale of 0 (no pain) to 10 (maximum pain)
Pain score 48h postoperativelyTwo days after surgeryReported pain in a scale of 0 (no pain) to 10 (maximum pain)

Secondary

MeasureTime frameDescription
Opioid-related side effects 48h postoperativelyTwo days after surgeryOpioid-related side effects
Opioid-related side effects 72h postoperativelyThree days after surgeryOpioid-related side effects
Opioid-related side effects 24h postoperativelyOne day after surgeryOpioid-related side effects

Countries

Brazil

Contacts

Primary ContactFelipe C Machado, MD, PhD
felipe.chiodini@hc.fm.usp.br+551126616335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026