AnesthesiaPhase 4NCT06720415
Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
A Phase 4 study testing Oral methadone, immediately prior to transport and Intravenous methadone in people with Anesthesia and Cardiac Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Cardiac Surgery
- What is being tested?
- Oral methadone, immediately prior to transport and Intravenous methadone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 14 Jul 2025
- Phase
- Phase 4
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
- Undergoing elective cardiac surgery as the first case of the day in an operating room
Who cannot join
- Chronic pain requiring opioid medications as an outpatient
- Opioid use disorder on medication assistance treatment
- Prolonged QTc > 500ms
- Chronic kidney disease with eGFR < 30mL/min
- Documented cirrhosis
- Intolerance to methadone
- Subsequent surgeries after index surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Comparison of Oral and Intravenous Methadone for Analgesia in Cardiac Surgery
The purpose of this study is to compare the effects of administration of oral methadone preoperatively and intravenous methadone upon induction of general anesthesia on postoperative pain for patients undergoing elective cardiac surgery.
- Conditions
- Anesthesia, Cardiac Surgery
- Being tested
- Oral methadone, immediately prior to transport, Intravenous methadone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral methadone, immediately prior to transportDrug
Patients will receive 0.4mg/kg PO methadone immediately prior to transport to the operating room
Intravenous methadoneDrug
Patients will receive 0.3mg/kg IV methadone after induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Oral methadone, immediately prior to transport | Experimental | Not described Receives: Drug: Oral methadone, immediately prior to transport |
| Intravenous methadone | Active comparator | Not described Receives: Drug: Intravenous methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use in Morphine Milligram Equivalents 24 Hours After Extubation
Oral morphine milligram equivalents
Measured: From hospital admission for surgery to 24 hours after the patient is extubated postoperatively
Secondary outcomes (9)
Opioid Use in Morphine Milligram Equivalents 48 Hours After Extubation
Oral morphine milligram equivalents
Measured: From hospital admission for surgery to 48 hours after the patient is extubated postoperatively
Opioid Use in Morphine Milligram Equivalents 72 Hours After Extubation
Oral morphine milligram equivalents
Measured: From hospital admission for surgery to 72 hours after the patient is extubated postoperatively
Pain Score 6 Hours After Extubation
Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: From hospital admission for surgery to 6 hours after extubation postoperatively
Pain Score 12 Hours After Extubation
Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: From hospital admission for surgery to 12 hours after extubation postoperatively
Pain Score 24 Hours After Extubation
Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: From hospital admission for surgery to 24 hours after extubation postoperatively
Pain Score 48 Hours After Extubation
Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: From hospital admission for surgery to 48 hours after extubation postoperatively
Pain Score 72 Hours After Extubation
Pain will be assessed using a numerical rating scale from 0-10, with 0 being no pain and 10 being the worst pain imaginable.
Measured: From hospital admission for surgery to 72 hours after extubation postoperatively
Time to Extubation
This outcome will monitor the time in minutes from when a patient arrives in the ICU to the time the breathing tube is removed (extubation).
Measured: From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated.
Opioid Use in MMEs Prior to Extubation
This outcome will assess the need for pain medications (opioids) to make patients comfortable prior to removing the breathing tube (extubation).
Measured: From the time the patient arrives in the ICU intubated until the time the patient is successfully extubated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start14 Apr 2025
- Primary completion7 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krishnan Ramanujan, Mayo Clinic
- Investigators
- Krishnan Ramanujan, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720415
- Sponsor's protocol ID
- 24-006579
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2024
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No