Methadone in Cystectomy Patients

NCT04475029 | Completed

• 2 other identifiers: 0045812019-004581-18
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The role of a single-dose intraoperative methadone on postoperative pain and opioid consumption in patients undergoing Surgeon Accuracy Robot Assistant cystectomy. A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing robotassisted cystectomy.

Conditions

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Bladder Cancer; Pain; Signs and Symptoms; Neurologic Manifestations; Neurologic Symptoms; Side Effect of Drug

Keywords

morphine; methadone; analgesics; opioids; effect of drugs

Outcome Measures

Primary Outcomes (2)

• Opioid consumption (morphine mg equivalents)

  • Opioid consumption within the first 3 hours after extubation

  3 hours

• Opioid consumption (morphine mg equivalents)

  • Opioid consumption within the first 24 hours after extubation

  24 hours

Secondary Outcomes (7)

• Pain intensity

  within 24 hours

• Opioid consumption (morphine mg equivalents)

  72 hours

• PONV

  Within 24 hours

• Level of sedation

  3 hours

• Adverse events

  6 hours

Other Outcomes (3)

• Pain intensity

  32-72 hours

• PONV

  32-72 hours

• Gastrointestinal function

  6-72 hours

Study Arms (2)

Methadone

EXPERIMENTAL

A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.

Drug: Methadone

Morphine

ACTIVE COMPARATOR

A 10 ml syringe with 2 mg/ml of morphine will be prepared and and study drug will be administered as intravenous bolus dose (0.15 mg/kg treatment weight (height (cm) - 100)). The study drug will be administered 1 hour prior to expected extubation.

Drug: Morphine

Interventions

Methadone DRUG

One intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.

Methadone

Morphine DRUG

One intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.

Morphine

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients (≥18 years) scheduled for elective robot assisted cystectomy.

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical status IV or V
• Prolonged QTc-interval assessed by electrocardiogram (\> 440 milliseconds)
• Existing treatment with a high risk of QTc-interval prolongation
• Allergy to study drugs
• Preoperative daily use of opioids
• Inability to provide informed consent
• Severe respiratory insufficiency (oxygen treatment at home)
• Heart failure (ejection fraction \< 30%)
• Acute abdominal pain
• Signs of severe liver dysfunction (cirrhosis, inflammation/hepatitis or liver malignancy)
• Severe kidney insufficiency (estimated Glomerular Filtration Rate \< 30 ml/min)
• Treatment with rifampicin
• Phaeochromocytoma
• Treatment with MAO-inhibitor during the last 14 days
• Pregnancy

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Urinary Bladder Neoplasms; Pain; Signs and Symptoms; Neurologic Manifestations

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization and medication will be handled by hospital pharmacy. Randomisation list will be concealed until all statistical analyses are made. * plan for data analysis was decided upon at a meeting with a statistician on September 7th, 2023. The plan was made before A and B lists were obtained from the hospital pharmacy. This study will be undertaken as an equivalence trial with the application of intention to treat analysis. Missing data are assumed to be missing at random. Primary outcome will be analyzed paired or unpaired t-test for difference, depending on distribution. Analysis of secondary outcome NRS will be reported as median(interquartile range) and compared between groups at the various times using the Mann-Whitney U test. If normal distributed multilevel mixed effects linear regression will be carried out. Analysis of other secondary outcomes will be dichotomized and presented for 3 and 24 hours with X2 test.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial.

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 17, 2020
• Study Start: July 6, 2020
• Primary Completion: August 15, 2023
• Study Completion: August 17, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)