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

Recruiting

Conditions: Esophageal cancer, Esophagectomy, gastric cancer, gastrectomy, music, perioperative patient care, stress response to surgery.Slokdarmkanker, slokdarmresectie, maagkanker, maagresectie, muziek, perioperatieve patientenzorg, chirurgische stress respons

Registration Number: NL-OMON23998

Lead Sponsor: Erasmus MC, University Medical Center Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

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

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
1.Patients using systemic steroid, immunosuppressant or cytotoxic medication at the moment of music intervention
2.Known hearing impairment or use of an hearing aid
3.Insufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher
4.Objection to any unknown music
5.Patients with locally advanced, unresectable esophageal or stomach cancer

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is postoperative pain (Numeric Rating Scale (NRS)).

Secondary Outcome Measures

Name	Time	Method
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.