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: 17.1 Level: PT Classification code 10019909 Term: Hernia System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Sponsors
Department of Anaesthesiology
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary outcome: Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg. ;Secondary Objective: -Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale) -Duration of operating time (from first incision to last suture) -Duration of suturing the hernia (minutes) -Assessments if the surgical space is better, unchanged or worse when evaluating before and after the intervention -Number of sudden contractions of the abdominal wall during operation (bucking or coughing), -Number of insufflator alarms where pneumoperitoneum > 17 mmHg, -Number of episodes with continuous abdominal contractions where the abdomen feels ”tight” but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall). - Number of recurrences of hernias by 2 year follow-up (separate publication). ;Primary end point(s): Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg. ;Timepoint(s) of evaluation of this end point: During operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes: (comparing Group A with Group B) -Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale) -Duration of operating time (from first incision to last suture) -Duration of suturing the hernia (minutes) -Assessments if the surgical space is better, unchanged or worse when evaluating before and after the intervention -Number of sudden contractions of the abdominal wall during operation (bucking or coughing), -Number of insufflator alarms where pneumoperitoneum > 17 mmHg, -Number of episodes with continuous abdominal contractions where the abdomen feels ”tight” but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall). - Number of recurrences of hernias by 2 year follow-up (separate publication). ;Timepoint(s) of evaluation of this end point: During operation and 2 years after surgery | — |
Countries
Denmark
Contacts
Public ContactMona Ring Gätke
Department of Anaesthesiology
Outcome results
None listed