Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade

NCT ID: NCT02247466

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-02-23

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.

Conditions

Laparoscopic Herniotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A - Saline, assesment, rocuronium and assesment

Intervention after intubation and placement of trocars without NMB. Bolus of saline (placebo) 6mL (TOF 100%) the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. After administration of rocuronium 0.6 mg/kg when TOF=0 the surgical workspace is assessed again

Group Type: ACTIVE_COMPARATOR

Rocuronium and Sugammadex

Intervention Type: DRUG

Group B - Rocuronium, assesment, sugammadex and assesment

Intervention after intubation and placement of trocars without NMB. Bolus of rocuronium 0.6 mg/kg when TOF=0 the surgeon assesses the surgical workspace with pneumoperitoneum 12 mmHg. Three minutes after administration of sugammadex (TOF 100%) the surgical workspace is assessed again

Group Type: ACTIVE_COMPARATOR

Rocuronium and Sugammadex

Intervention Type: DRUG

Interventions

Rocuronium and Sugammadex

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Roar Medici

MD, research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Ring Gätke, MD, Ph.D.

Role: STUDY_CHAIR

Department of Anaesthesiology, Herlev Hospital

Locations

Gentofte Hospital

Hellerup, Capital Region, Denmark

Herlev Hospital

Herlev, Capital Region, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29878947 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26239595 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NMBDKHernia2014

Identifier Type: -

Identifier Source: org_study_id