Intraoperative Music to PROMote PaTient oUtcome (IMPROMPTU): a double-blind, placebo-controlled, randomized multicenter trial

Category Primary study
Registry of TrialsOverview of Medical Research in the Netherlands (OMON)
Year 2018
INTERVENTION: Patients will be randomly allocated to one of two study arms. The intervention group will receive intraoperative music as an intervention; the control group will not hear music. All participants will wear headphones during surgery. The music intervention will consist of a preselected playlist of music based on recommendations of literature. CONDITION: Esophageal cancer, Esophagectomy, gastric cancer, gastrectomy, music, perioperative patient care, stress response to surgery. Slokdarmkanker, slokdarmresectie, maagkanker, maagresectie, muziek, perioperatieve patientenzorg, chirurgische stress respons PRIMARY OUTCOME: The primary outcome is postoperative pain (Numeric Rating Scale (NRS)). SECONDARY OUTCOME: Secondary outcomes are intraoperative medication requirement (intraoperative propofol, opioids and catecholamines), postoperative opioid requirement, stress response to surgery (serum cortisol, tumor necrosis factor alpha (TNF‐α), interleukin‐6 (IL‐6), C‐reactive protein (CRP)), intraoperative vital parameters, postoperative complications, hospital length of stay and 30‐day mortality. INCLUSION CRITERIA: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients undergoing elective surgical esophageal or stomach cancer resection 2. Age ≥ 18 years 3. Provision of written informed consent by the patient
Epistemonikos ID: 7a99e51218ccd9b305951c35263e4c2466535f4d
First added on: Aug 24, 2024