Optimizing surgical conditions in surgery for hernia with or without use of muscle relaxation (The hernia study)

Phase 1

• Conditions: The purpose of this study is to investigate surgical work space and surgical conditions in patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The patients will act as their own control with evaluation of surgical work space and surgical conditions during both deep NMB and no NMB.; MedDRA version: 17.1Level: PTClassification code 10019909Term: HerniaSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-002802-19-DK
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-03
• Last Update Posted: 10 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Patients > 18 years old
Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba herniotomy
Can read and understand Danish
Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

Known allergy to sugammadex or rocuronium
Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis)
Neuromuscular disease that may interfere with neuromuscular data
Lactating or pregnant
Indication for rapid sequence induction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified