Optimizing Surgical Conditions During Laparoscopic Umbilical, Incisional -and Linea Alba Herniotomy With Deep Neuromuscular Blockade

Condition(s) targeted: Laparoscopic Herniotomy

Intervention: Rocuronium and Sugammadex (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Herlev Hospital

Official(s) and/or principal investigator(s):
Mona Ring Gätke, MD, Ph.D., Study Chair, Affiliation: Department of Anaesthesiology, Herlev Hospital

Overall contact:
Roar Medici, MD, Phone: +45 26 39 00 68, Email: roar.borregaard.medici.01@regionh.dk

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.

Official title: Optimizing Surgical Conditions During Laparoscopic Umbilical, Incisional -and Linea Alba Herniotomy With Deep Neuromuscular Blockade

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Improvement of surgical workspace

Secondary outcome:

Surgical conditions while suturing

operating time

suturing time

Surgical space comparison

Contractions

Insufflator alarms

Continuous abdominal contractions

recurrences of hernias

Detailed description: Umbilical herniotomy is a frequent surgical procedure worldwide, and the larger hernia defects are preferably operated by laparoscopic technique. The advantages of the laparoscopic approach are shorter convalescence with earlier mobilization, and less wound complications [1]. A preferred approach is currently to close the defect by laparoscopic suturing in order to reduce the formation of seroma in the hernia sac [2] , and then apply a mesh by intraperitoneal onlay technique (IPOM technique). However, it may be difficult to suture the defect if there is tension in the abdominal wall muscles together with the applied pneumoperitoneum. There is evidence that muscle relaxation improves conditions for endotracheal intubation[3] and reduces laryngeal morbidity but only a few studies investigate the necessity of relaxation during laparoscopic surgery [4]. During laparoscopic surgery muscle relaxation is used with great variability. Sometimes the procedure is performed without muscle relaxation and sometimes with a so-called surgical neuromuscular blockade, which with objective neuromuscular monitoring means that train-of-four (TOF) is kept at 3-4 responses to nerve stimulation of the ulnar nerve. In this way there is a great variability in the neuromuscular blockade and rarely the patients are receiving deep neuromuscular blockade. Traditionally, neuromuscular monitoring is done by measuring the muscle strength of the adductor pollicis muscle on the thumb. The response to TOF nerve stimulation may be zero, while muscle relaxation of more resistant muscles such as the abdominal muscles and the diaphragm [5;6] are not complete which means that the patients may cough and their abdominal wall may feel "tight" during surgery, even though no response at the thumb is recorded. It is possible to quantify a deep neuromuscular block by the use of post-tetanic-count (PTC). With establishment of deep, continuous neuromuscular blockade with PTC value 0-1 all muscles including abdominal muscles and diaphragm are paralyzed [7]. It is therefore possible, that a deep neuromuscular blockade (NMB) where the diaphragm and the abdominal wall muscles are more paralyzed will optimize the surgical work space, ease the surgical procedure, reduce operative time for the suturing part of the procedure as well as the total procedure time, and reduce the number of recurrences by long term follow-up. 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. Hypothesis: Deep NMB defined as TOF=0 and post-tetanic count PTC ≥1, will give better surgical workspace, better surgical conditions, as well as shorter duration of surgery and reduced number of recurrences of hernias compared with no NMB.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients > 18 years old

- Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba -

herniotomy

- Can read and understand Danish

- Informed consent

Exclusion Criteria:

- Known allergy to sugammadex, rocuronium or mivacurium

- Known homozygous variants in the butyrylcholinesterase gene

- 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 (Women of child bearing potential must take a urine pregnancy

test at the day of the operation. The test will be provided by the hospital staff).

- Indication for rapid sequence induction

Roar Medici, MD, Phone: +45 26 39 00 68, Email: roar.borregaard.medici.01@regionh.dk

Gentofte Hospital, Hellerup, Region Hovedstaden 2900, Denmark; Recruiting
Roar B Medici, MD, Phone: 26390068, Ext: 0045, Email: roar.borregaard.medici.01@regionh.dk
Roar B Medici, MD, Principal Investigator

Starting date: February 2015
Last updated: May 7, 2015