C61
Conditions
Interventions
Group 1: This prospective, single arm, non randomised study will include 400 adult male patients undergoing elective robot assisted radical prostatectomy for prostate cancer under general anaesthesia.
Sponsors
Marien Hospital Herne
Eligibility
Sex/Gender
Male
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: Male patients aged 35 to 80 years. Elective robot assisted radical prostatectomy for prostate cancer. Planned surgery under general anaesthesia. ASA physical status I to III. Written informed consent after oral and written information. Ability to understand the study information and to complete the questionnaires provided in German.
Exclusion criteria
Exclusion criteria: Missing or withdrawn written informed consent. Relevant language barrier preventing comprehension of the study information or completion of the questionnaires provided in German. Renal impairment greater than KDIGO stage 2. Neurological or neuromuscular disease. Diagnosed dementia or preoperative delirium. Body weight outside a range of plus or minus 20 percent of ideal body weight. Severe visual or hearing impairment preventing valid completion of study assessments. Known allergy or hypersensitivity to rocuronium or propofol. Concurrent participation in another interventional or experimental research study. ASA physical status greater than III.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the lowest amplitude of the first muscle response following intravenous administration of 0.3 mg per kilogram rocuronium. The value will be expressed as the percentage ratio of the first muscle response to the control amplitude measured before rocuronium administration. Neuromuscular response will be measured immediately before rocuronium administration and continuously from the time of administration until the lowest value is reached. The maximum observation period for determination of the primary outcome is ten minutes. The association between the primary outcome and predefined genetic polymorphisms in genes involved in neuromuscular transmission, drug transport and drug regulation will be analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of neuromuscular blockade, defined as the time from the first administration of rocuronium until the lowest value of the first muscle response is reached. Time until recovery of the first muscle response to 25 percent of the baseline value. Recovery index, defined as the time required for recovery of the first muscle response from 25 percent to 75 percent of the baseline value. Time until complete neuromuscular recovery with a train of four ratio of at least 0.9. Incidence of postoperative delirium assessed using CAM ICU in the post anaesthesia care unit and 3D CAM up to and including postoperative day three. Quality of recovery assessed using the QoR15 questionnaire before surgery, on postoperative day one and on postoperative day 30. Incidence of postoperative nausea and vomiting during the hospital stay. Postoperative pain and perioperative analgesic consumption until hospital discharge. Postoperative complications classified according to Clavien Dindo and summarised using the Comprehensive Complication Index at hospital discharge. Hospital readmissions, delayed postoperative complications and subjective quality of recovery on postoperative day 30. | — |
Countries
Germany
Contacts
Public ContactUlrich Frey
Marien Hospital Hene
Outcome results
None listed