Methadone Anesthesia For Kidney Transplant Receptors
Primary Purpose
Renal Failure Chronic, Surgery
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Methadone
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure Chronic
Eligibility Criteria
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).
Sites / Locations
- Hospital das Clínicas da FMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methadone
Fentanyl
Arm Description
Methadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery
Fentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery
Outcomes
Primary Outcome Measures
Pain score 24h postoperatively
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Pain score 48h postoperatively
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Pain score 72h postoperatively
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Analgesic use 24h postoperatively
Analgesic use after surgery
Analgesic use 48h postoperatively
Analgesic use after surgery
Analgesic use 72h postoperatively
Analgesic use after surgery
Secondary Outcome Measures
Opioid-related side effects 24h postoperatively
Opioid-related side effects
Opioid-related side effects 48h postoperatively
Opioid-related side effects
Opioid-related side effects 72h postoperatively
Opioid-related side effects
Full Information
NCT ID
NCT04908345
First Posted
May 20, 2021
Last Updated
May 25, 2021
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04908345
Brief Title
Methadone Anesthesia For Kidney Transplant Receptors
Official Title
Intraoperative Use Of Methadone In The Prevention of Postoperative Pain in Kidney Transplant Receptors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Methadone x Fentanyl
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
Experimental
Arm Description
Methadone 0,075mg/kg for induction and half of induction dose of boluses as needed during surgery
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Fentanyl 3 mcg/kg for induction and half of induction dose of boluses as needed during surgery
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Used at induction and during surgery
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Used at induction and during surgery
Primary Outcome Measure Information:
Title
Pain score 24h postoperatively
Description
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Time Frame
One day after surgery
Title
Pain score 48h postoperatively
Description
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Time Frame
Two days after surgery
Title
Pain score 72h postoperatively
Description
Reported pain in a scale of 0 (no pain) to 10 (maximum pain)
Time Frame
Three days after surgery
Title
Analgesic use 24h postoperatively
Description
Analgesic use after surgery
Time Frame
One day after surgery
Title
Analgesic use 48h postoperatively
Description
Analgesic use after surgery
Time Frame
Two days after surgery
Title
Analgesic use 72h postoperatively
Description
Analgesic use after surgery
Time Frame
Three days after surgery
Secondary Outcome Measure Information:
Title
Opioid-related side effects 24h postoperatively
Description
Opioid-related side effects
Time Frame
One day after surgery
Title
Opioid-related side effects 48h postoperatively
Description
Opioid-related side effects
Time Frame
Two days after surgery
Title
Opioid-related side effects 72h postoperatively
Description
Opioid-related side effects
Time Frame
Three days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe C Machado, MD, PhD
Phone
+551126616335
Ext
6335
Email
felipe.chiodini@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe C Machado, MD, PhD
Organizational Affiliation
USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Machado, MD
Phone
+551126617947
Email
felipe.chiodini@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Methadone Anesthesia For Kidney Transplant Receptors
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