A Phase 4 interventional study of Rocuronium and Sugammadex in Laparoscopic Herniotomy, sponsored by Herlev Hospital. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Herlev Hospital · Phase 4, Interventional, and Treatment
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.
Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
Operating Time
Duration of operating time (from first incision to last suture)
Time frame: 3 hours
Suturing Time
Duration of suturing the hernia (minutes)
Time frame: 3 hours
Contractions
Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions
Time frame: 3 hours
Insufflator Alarms
Insufflator alarms where pneumoperitoneum \> 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum \> 17 mmHg
Time frame: 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)
Time frame: 3 hours
Recurrences of Hernias
Number of recurrences of hernias by 2 year follow-up (separate publication).
Time frame: 2 years
| Milestone | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Started | 19 | 18 |
| Completed | 19 | 15 |
| Not completed | 0 | 3 |
| Withdrew: Procedure changed to open surgery | 0 | 3 |
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)
| Participants | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Changes in ratings 5 to 3 | 0 | 1 |
| Changes in ratings 4 to 3 | 0 | 0 |
| Changes in ratings 5 to 4 | 0 | 4 |
| Changes in ratings 3 to 3 | 1 | 0 |
| Changes in ratings 4 to 4 | 1 | 2 |
| Changes in ratings 5 to 5 | 14 | 4 |
| Changes in ratings 4 to 5 | 2 | 2 |
| Changes in ratings 3 to 4 | 0 | 1 |
| Changes in ratings 3 to 5 | 1 | 1 |
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)
| Participants | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| 1. Extremely poor conditions | 0 | 0 |
| 2. Poor conditions | 0 | 0 |
| 3. Acceptable conditions | 0 | 2 |
| 4. Good conditions | 3 | 4 |
| 5. Optimal conditions | 16 | 7 |
Duration of operating time (from first incision to last suture)
| minutes | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Operating Time | 61 (37 to 85) | 64 (33 to 95) |
Duration of suturing the hernia (minutes)
| minutes | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Suturing Time | 10 (1 to 19) | 9 (2 to 16) |
Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions
| Participants | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Contractions | 1 | 0 |
Insufflator alarms where pneumoperitoneum \> 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum \> 17 mmHg
| Participants | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Insufflator Alarms | 0 | 0 |
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)
| Participants | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment |
|---|---|---|
| Continuous Abdominal Contractions | 0 | 0 |
Number of recurrences of hernias by 2 year follow-up (separate publication).
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A - Saline, Assesment, Rocuronium and Assesment | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Group B - Rocuronium, Assesment, Sugammadex and Assesment | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| Mean | 57 ± 17 | 55 ± 15 | 56.4 ± 15.5 |
| Sex: Female, Male(Participants) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 15 | 10 | 25 |
| Race and Ethnicity Not Collected(Participants) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(kg/m2) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| Mean | 28 ± 4 | 30 ± 4 | 29 ± 4.17 |
| ASA 1/2/3(Participants) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| ASA 1 | 5 | 4 | 9 |
| ASA 2 | 12 | 10 | 22 |
| ASA 3 | 2 | 1 | 3 |
| Previous abdominal surgery(Participants) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| Count of participants | 12 | 10 | 22 |
| Herniea size (cm)(cm) | Group A - Saline, Assesment, Rocuronium and Assesment | Group B - Rocuronium, Assesment, Sugammadex and Assesment | Total |
|---|---|---|---|
| Mean | 2.4 ± 1.5 | 3.1 ± 2.1 | 2.72 ± 1.82 |
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Herlev Hospital