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

Completed

• Conditions: esophageal and gastric cancer surgery; gullet and stomach cancer surgery; 10017990; 10017998

• Registration Number: NL-OMON48702
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Patients undergoing elective esophageal or stomach cancer surgery
2. Age * 18 years
3. Provision of written informed consent by the patient

Exclusion Criteria

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
<p>Postoperative pain (NRS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Intraoperative medication requirement<br /><br>- Postoperative opioid requirement<br /><br>- Stress response to surgery (serum total cortisol, tumor necrosis factor alpha<br /><br>(TNF-*), interleukin-6 (IL-6) and C-reactive protein (CRP))<br /><br>- Postoperative complications<br /><br>- Hospital length of stay<br /><br>- 30-day mortality</p><br>