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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02247466
Enrollment
37
Registered
2014-09-25
Start date
2015-02-28
Completion date
2017-02-23
Last updated
2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Herniotomy

Keywords

Neuromuscular Blockade, Laparoscopy

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.

Interventions

DRUGRocuronium and Sugammadex

Sponsors

Herlev Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of Surgical Workspace3 hoursImprovement 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

MeasureTime frameDescription
Operating Time3 hoursDuration of operating time (from first incision to last suture)
Suturing Time3 hoursDuration of suturing the hernia (minutes)
Contractions3 hoursSudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions
Surgical Conditions While Suturing3 hoursSurgeon´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)
Continuous Abdominal Contractions3 hoursNumber 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)
Recurrences of Hernias2 yearsNumber of recurrences of hernias by 2 year follow-up (separate publication).
Insufflator Alarms3 hoursInsufflator alarms where pneumoperitoneum \> 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum \> 17 mmHg

Countries

Denmark

Participant flow

Participants by arm

ArmCount
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
19
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
15
Total34

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProcedure changed to open surgery03

Baseline characteristics

CharacteristicGroup A - Saline, Assesment, Rocuronium and AssesmentGroup B - Rocuronium, Assesment, Sugammadex and AssesmentTotal
Age, Continuous57 years
STANDARD_DEVIATION 17
55 years
STANDARD_DEVIATION 15
56.4 years
STANDARD_DEVIATION 15.5
ASA 1/2/3
ASA 1
5 Participants4 Participants9 Participants
ASA 1/2/3
ASA 2
12 Participants10 Participants22 Participants
ASA 1/2/3
ASA 3
2 Participants1 Participants3 Participants
BMI28 kg/m2
STANDARD_DEVIATION 4
30 kg/m2
STANDARD_DEVIATION 4
29 kg/m2
STANDARD_DEVIATION 4.17
Herniea size (cm)2.4 cm
STANDARD_DEVIATION 1.5
3.1 cm
STANDARD_DEVIATION 2.1
2.72 cm
STANDARD_DEVIATION 1.82
Previous abdominal surgery12 Participants10 Participants22 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
4 Participants5 Participants9 Participants
Sex: Female, Male
Male
15 Participants10 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 15
other
Total, other adverse events
0 / 190 / 15
serious
Total, serious adverse events
0 / 190 / 15

Outcome results

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)

Time frame: 3 hours

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 4 to 41 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 3 to 51 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 5 to 514 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 4 to 52 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 3 to 40 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 5 to 30 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 4 to 30 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 5 to 40 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentImprovement of Surgical WorkspaceChanges in ratings 3 to 31 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 5 to 44 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 5 to 31 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 4 to 42 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 3 to 41 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 5 to 54 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 4 to 30 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 4 to 52 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 3 to 30 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentImprovement of Surgical WorkspaceChanges in ratings 3 to 51 Participants
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)

Time frame: 3 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group A - Saline, Assesment, Rocuronium and AssesmentContinuous Abdominal Contractions0 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentContinuous Abdominal Contractions0 Participants
Secondary

Contractions

Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions

Time frame: 3 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group A - Saline, Assesment, Rocuronium and AssesmentContractions1 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentContractions0 Participants
Secondary

Insufflator Alarms

Insufflator alarms where pneumoperitoneum \> 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum \> 17 mmHg

Time frame: 3 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group A - Saline, Assesment, Rocuronium and AssesmentInsufflator Alarms0 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentInsufflator Alarms0 Participants
Secondary

Operating Time

Duration of operating time (from first incision to last suture)

Time frame: 3 hours

ArmMeasureValue (MEAN)
Group A - Saline, Assesment, Rocuronium and AssesmentOperating Time61 minutes
Group B - Rocuronium, Assesment, Sugammadex and AssesmentOperating Time64 minutes
Secondary

Recurrences of Hernias

Number of recurrences of hernias by 2 year follow-up (separate publication).

Time frame: 2 years

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)

Time frame: 3 hours

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Group A - Saline, Assesment, Rocuronium and AssesmentSurgical Conditions While Suturing3. Acceptable conditions0 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentSurgical Conditions While Suturing5. Optimal conditions16 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentSurgical Conditions While Suturing2. Poor conditions0 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentSurgical Conditions While Suturing4. Good conditions3 Participants
Group A - Saline, Assesment, Rocuronium and AssesmentSurgical Conditions While Suturing1. Extremely poor conditions0 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentSurgical Conditions While Suturing5. Optimal conditions7 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentSurgical Conditions While Suturing2. Poor conditions0 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentSurgical Conditions While Suturing3. Acceptable conditions2 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentSurgical Conditions While Suturing4. Good conditions4 Participants
Group B - Rocuronium, Assesment, Sugammadex and AssesmentSurgical Conditions While Suturing1. Extremely poor conditions0 Participants
Secondary

Suturing Time

Duration of suturing the hernia (minutes)

Time frame: 3 hours

ArmMeasureValue (MEAN)
Group A - Saline, Assesment, Rocuronium and AssesmentSuturing Time10 minutes
Group B - Rocuronium, Assesment, Sugammadex and AssesmentSuturing Time9 minutes

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026