Clinical trial NCT02247466: Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade
Official title: Optimizing Surgical Conditions During Laparoscopic Umbilical, Incisional -and Linea Alba Herniotomy With Deep Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Herniotomy
Keywords: Neuromuscular Blockade
Laparoscopy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Improvement of Surgical Workspace
timeFrame: 3 hours
Secondary outcomes:
measure: Surgical Conditions While Suturing
timeFrame: 3 hours
measure: Operating Time
timeFrame: 3 hours
measure: Suturing Time
timeFrame: 3 hours
measure: Contractions
timeFrame: 3 hours
measure: Insufflator Alarms
timeFrame: 3 hours
measure: Continuous Abdominal Contractions
timeFrame: 3 hours
measure: Recurrences of Hernias
timeFrame: 2 years
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
state: Region Hovedstaden
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Region Hovedstaden
Study officials:
affiliation: Department of Anaesthesiology, Herlev Hospital
name: Mona Ring Gätke, MD, Ph.D.
role: STUDY_CHAIR
References:
citation: Soderstrom CM, Borregaard Medici R, Assadzadeh S, Folsgaard S, Rosenberg J, Gatke MR, Madsen MV. Deep neuromuscular blockade and surgical conditions during laparoscopic ventral hernia repair: A randomised, blinded study. Eur J Anaesthesiol. 2018 Nov;35(11):876-882. doi: 10.1097/EJA.0000000000000833.
citation: Medici R, Madsen MV, Asadzadeh S, Folsgaard S, Rosenberg J, Gatke MR. Neuromuscular blockade during laparoscopic ventral herniotomy: protocol for a randomised controlled trial. Dan Med J. 2015 Aug;62(8):A5120.