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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Saline, assesment, rocuronium and assesment | Active Comparator | 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 B - Rocuronium, assesment, sugammadex and assesment | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium and Sugammadex | Drug |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Ring Gätke, MD, Ph.D. | Department of Anaesthesiology, Herlev Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Hellerup | Capital Region | 2900 | Denmark | ||
| Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29878947 | Derived | 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. | |
| 26239595 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Rocuronium and Sugammadex |
| FG001 | 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 Rocuronium and Sugammadex |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Rocuronium and Sugammadex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | 3 hours |
|
Patients will be observed during their stay at the hospital and will be contacted by telephone on first and seventh postoperative day. Possibly adverse events during this period will be reported. Finally the patient´s case files will be reviewed for reports of adverse events at 17-21 days after operation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Rocuronium and Sugammadex |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roar Borregaard Medici, MD, Research Assistant | Department of Anaesthesiology, Herlev Hospital, University of Copenhagen | +4526390068 | roar.borregaard.medici.01@regionh.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2016 | Sep 19, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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 |
| Herlev |
| Capital Region |
| 2730 |
| Denmark |
| 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. |
| BG001 |
| 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 Rocuronium and Sugammadex |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| ASA 1/2/3 | american society of anesthesiologists Physical Status Classification System score. American Society of Anesthesiologists (ASA) Score is a global score that assesses the physical status of patients before surgery. It is sometimed refereed to as ASA-PS, because it is a measure of 'physical status'. ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive | Count of Participants | Participants |
|
| Previous abdominal surgery | Count of Participants | Participants |
|
| Herniea size (cm) | Mean | Standard Deviation | cm |
|
| 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 Rocuronium and Sugammadex |
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 3 hours |
|
|
|
| Secondary | Operating Time | Duration of operating time (from first incision to last suture) | Posted | Mean | Full Range | minutes | 3 hours |
|
|
|
| Secondary | Suturing Time | Duration of suturing the hernia (minutes) | Posted | Mean | Full Range | minutes | 3 hours |
|
|
|
| Secondary | Contractions | Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions | Posted | Count of Participants | Participants | 3 hours |
|
|
|
| Secondary | Insufflator Alarms | Insufflator alarms where pneumoperitoneum > 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum > 17 mmHg | Posted | Count of Participants | Participants | 3 hours |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | 3 hours |
|
|
|
| Secondary | Recurrences of Hernias | Number of recurrences of hernias by 2 year follow-up (separate publication). | Not Posted | 2 years | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 Rocuronium and Sugammadex | 0 | 15 | 0 | 15 | 0 | 15 |
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| D011083 |
| Polycyclic Compounds |
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| ASA 3 |
|
| 3. Acceptable conditions |
|
| 4. Good conditions |
|
| 5. Optimal conditions |
|