Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Herniotomy
• Intervention / Treatment: Drug: Rocuronium and Sugammadex

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Region Hovedstaden
    • Hellerup, Region Hovedstaden, Denmark, 2900
      • Gentofte Hospital
    • Herlev, Region Hovedstaden, Denmark, 2730
      • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Rocuronium and Sugammadex
Active Comparator: 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	Drug: Rocuronium and Sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Surgical Workspace	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. (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Conditions While Suturing	Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale) (1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)	3 hours
Operating Time	Duration of operating time (from first incision to last suture)	3 hours
Suturing Time	Duration of suturing the hernia (minutes)	3 hours
Contractions	Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions	3 hours
Insufflator Alarms	Insufflator alarms where pneumoperitoneum > 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum > 17 mmHg	3 hours
Continuous Abdominal Contractions	Number of patients experiencing 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)	3 hours
Recurrences of Hernias	Number of recurrences of hernias by 2 year follow-up (separate publication).	2 years

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Study Chair: Mona Ring Gätke, MD, Ph.D., Department of Anaesthesiology, Herlev Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): February 23, 2017
• Study Completion (Actual): February 23, 2017

Study Registration Dates

• First Submitted: September 19, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Laparoscopy; Neuromuscular Blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: NMBDKHernia2014