Renal Failure ChronicPhase 3NCT04908345
Methadone Anesthesia For Kidney Transplant Receptors
A Phase 3 study testing Methadone and Fentanyl in people with Renal Failure Chronic and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic, Surgery
- What is being tested?
- Methadone and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 17 May 2021to Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- With indication for kidney transplant surgery
- Who sign the informed consent form
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05403-000
Felipe Machado, MD, +551126617947, felipe.chiodini@hotmail.com
About this study
Official title: 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
Read the 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
- Conditions
- Renal Failure Chronic, Surgery
- Being tested
- Methadone, Fentanyl
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Used at induction and during surgery
FentanylDrug
Used at induction and during surgery
| Study group | Role | What they receive |
|---|---|---|
| Methadone | Experimental | Methadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery Receives: Drug: Methadone |
| Fentanyl | Active comparator | Fentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score 24h postoperatively
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Measured: One day after surgery
Pain score 48h postoperatively
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Measured: Two days after surgery
Pain score 72h postoperatively
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Measured: Three days after surgery
Analgesic use 24h postoperatively
Analgesic use after surgery
Measured: One day after surgery
Analgesic use 48h postoperatively
Analgesic use after surgery
Measured: Two days after surgery
Analgesic use 72h postoperatively
Analgesic use after surgery
Measured: Three days after surgery
Secondary outcomes (3)
Opioid-related side effects 24h postoperatively
Opioid-related side effects
Measured: One day after surgery
Opioid-related side effects 48h postoperatively
Opioid-related side effects
Measured: Two days after surgery
Opioid-related side effects 72h postoperatively
Opioid-related side effects
Measured: Three days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start17 May 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Methadone x Fentanyl
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Chiodini Machado, University of Sao Paulo General Hospital
- Investigators
- Felipe C Machado, MD, PhD, Principal investigator, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908345
- Sponsor's protocol ID
- MEFERENAL
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use Of Methadone In The Prevention of Postoperative Pain in Kidney Transplant Receptors
- ClinicalTrials.gov ID
- NCT04908345
- Acronym / sponsor ID
- MEFERENAL
- Conditions
- Renal Failure Chronic, Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Methadone x Fentanyl
| Arm | Type | Receives |
|---|---|---|
| Methadone | Experimental | Drug: MethadoneMethadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery |
| Fentanyl | Active comparator | Drug: FentanylFentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- With indication for kidney transplant surgery
- Who sign the informed consent form
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneUsed at induction and during surgery | Drug | Methadone |
| FentanylUsed at induction and during surgery | Drug | Fentanyl |
Primary outcome
Pain score 24h postoperatively
Time frame: One day after surgery
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Pain score 48h postoperatively
Time frame: Two days after surgery
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Pain score 72h postoperatively
Time frame: Three days after surgery
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Analgesic use 24h postoperatively
Time frame: One day after surgery
Analgesic use after surgery
Analgesic use 48h postoperatively
Time frame: Two days after surgery
Analgesic use after surgery
Analgesic use 72h postoperatively
Time frame: Three days after surgery
Analgesic use after surgery
3 secondary outcomes
Opioid-related side effects 24h postoperatively
Time frame: One day after surgery
Opioid-related side effects 48h postoperatively
Time frame: Two days after surgery
Opioid-related side effects 72h postoperatively
Time frame: Three days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe C Machado, MD, PhD principal investigator
USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone and Fentanyl in people with Renal Failure Chronic and Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Felipe C Machado, MD, PhD (+551126616335 ext. 6335, felipe.chiodini@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score 24h postoperatively (time frame: One day after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.