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Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade

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ClinicalTrials.gov Identifier: NCT02247466
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Roar Medici, Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Herniotomy Drug: Rocuronium and Sugammadex Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Surgical Conditions During Laparoscopic Umbilical, Incisional -and Linea Alba Herniotomy With Deep Neuromuscular Blockade
Study Start Date : February 2015
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Improvement of Surgical Workspace [ Time Frame: 3 hours ]

    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)



Secondary Outcome Measures :
  1. Surgical Conditions While Suturing [ Time Frame: 3 hours ]

    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)


  2. Operating Time [ Time Frame: 3 hours ]
    Duration of operating time (from first incision to last suture)

  3. Suturing Time [ Time Frame: 3 hours ]
    Duration of suturing the hernia (minutes)

  4. Contractions [ Time Frame: 3 hours ]
    Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions

  5. Insufflator Alarms [ Time Frame: 3 hours ]
    Insufflator alarms where pneumoperitoneum > 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum > 17 mmHg

  6. Continuous Abdominal Contractions [ Time Frame: 3 hours ]
    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)

  7. Recurrences of Hernias [ Time Frame: 2 years ]
    Number of recurrences of hernias by 2 year follow-up (separate publication).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247466


Locations
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Denmark
Gentofte Hospital
Hellerup, Region Hovedstaden, Denmark, 2900
Herlev Hospital
Herlev, Region Hovedstaden, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Study Chair: Mona Ring Gätke, MD, Ph.D. Department of Anaesthesiology, Herlev Hospital
  Study Documents (Full-Text)

Documents provided by Roar Medici, Herlev Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roar Medici, MD, research assistant, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02247466     History of Changes
Other Study ID Numbers: NMBDKHernia2014
First Posted: September 25, 2014    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Keywords provided by Roar Medici, Herlev Hospital:
Neuromuscular Blockade
Laparoscopy
Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs