- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564576
Neuromuscular Blockade and Surgical Conditions (Sugamadex)
The Influence of the Magnitude of Neuromuscular Blockade on the Surgical Conditions During Laparoscopic Sleeve Gastrectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In laparoscopic bariatric procedures, CO2 is used to insufflate the peritoneal cavity and increase the intra-abdominal pressure for optimal exposure and a suitable operating field. However, the increased intra-abdominal pressure during pneumoperitoneum has profound physiological effects including a reduction in urine output,portal venous flow,respiratory compliance,and cardiac output.
Abdominal muscle relaxation and changes in abdominal wall compliance, produced by the use of anesthetics and muscle relaxants, are important contributors for the achievement of optimal surgical field using minimal abdominal pressure. A practical dilemma is how to maintain good surgical conditions till the end of the operative procedure by deep anesthesia and muscle relaxation on one hand, and to have an awake and spontaneously breathing patient at the end of surgery on the other.
Reversal agents are often used to ensure the reversal of nondepolarizing neuromuscular blockade (NMB). The most widely used is the acetylcholinesterase inhibitor neostigmine (Prostigmin®, Vagostigmin®). However, neostigmine is only partially effective when NMB is deep (less then 1 response using train of four monitoring) and may also be associated with adverse effects, such as cholinergic cardiovascular and gastrointestinal events.Sugammadex (bridion®) is a modified gamma cyclodextrin specifically designed for the reversal of NMB induced by the aminosteroid muscle relaxants including rocuronium bromide (Zemuron®, Esmeron®). Sugammadex (bridion®) acts by encapsulating unbound rocuronium bromide (Zemuron®, Esmeron®)molecules and reducing their concentration at the neuromuscular junction.Studies in surgical patients have shown that sugammadex (bridion®) rapidly and safely reverses rocuronium bromide (Zemuron®, Esmeron®)induced NMB. Unlike acetylcholinesterase inhibitors, sugammadex (bridion®) is also effective in the reversal of deep NMB (no response in train of four monitoring or even no response in post tetanic count monitoring).
Laparoscopic weight reduction surgery requires the appropriate use of muscle relaxation; however, uncertainty remains including indeterminate dosing and unpredictable effect. Additionally, the time to the recovery to a train of four (TOF) ratio of 0.9 in the obese [25.9 (6.7, 13.5-41.0) min] and the overweight groups [14.6 (7.7, 3.3-28.5) min] were significantly longer than that in the normal weight group [6.9 (2.0, 3.0-10.7) min]. Therefore, obese patients are at increased risk for residual muscle relaxation following surgery. Sugammadex (bridion®) has recently been found to reach a peak effect faster than neostigmine(Prostigmin®, Vagostigmin®), in obese patients. In this study, the time to a TOFR ≥ 0.9 was 13 min with 50 μg/kg neostigmine (Prostigmin®, Vagostigmin®)and only 1.7 min with 2 mg/kg sugammadex. Therefore, it appears that sugammadex (bridion®) may more predictably prevent the occurrence of residual muscle relaxation compared to neostigmine (Prostigmin®, Vagostigmin®).
The aim of the present study is to prospectively assess whether deep NMB (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) till the end of surgery, followed by sugammadex (bridion®) reversal is superior to the present practice of gradual NMB reduction at the end of surgery followed by neostigmine (Prostigmin®, Vagostigmin®)reversal, in patients undergoing laparoscopic sleeve gastrectomy. The investigators hypothesize that providing deep NMB throughout the procedure creates better conditions for surgery, while reversal of deep muscle relaxation with sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®) reversal. Surgical conditions will be assessed by the surgeons, blinded to the treatment given to the patients, on a 1-4 Likert scale in 5 minutes intervals from abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes). Participants will be followed for respiratory adverse events from admission to the post anesthesia care unit to discharge to the surgical department (continuous measurement of hemoglobin oxygen saturation and respiratory rate for an expected average of 3 hours) and from admission to the surgical department till the time of home discharge (measurement of hemoglobin oxygen saturation and respiratory rate every 6 hours for an expected average of 5 days).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tel Hashomer, Israel
- Sheba Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists physical status Class I-III, scheduled to undergo elective sleeve gastrectomy
Exclusion Criteria:
- Neuromuscular disorder affecting NMB
- history of malignant hyperthermia
- significant renal dysfunction
- allergy to medications used during general anesthesia
- concurrent use of medications known to interfere with NMBAs or with sugammadex (antibiotics, anticonvulsants, magnesium salts).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Conventional neuromuscular blockade
The dose of rocuronium (medication used for NMB during anesthesia)will be adjusted to maintain a depth of NMB of T1 of 10-20% as assessed by a nerve stimulator.
At the end of surgery patients will receive neostigmine 2.5 mg and atropine 1 mg to reverse the effect of rocuronium.
Extubation will be performed when train-of-four ratio ≥ 0.9.
|
Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses.
At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12.
Extubation will be performed when train-of-four ratios ≥ 0.9.
Other Names:
|
Experimental: Profound neuromuscular blockade
Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses.
At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12.
Extubation will be performed when train-of-four ratios ≥ 0.9.
|
Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses.
At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12.
Extubation will be performed when train-of-four ratios ≥ 0.9.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective surgeon feedback on the exposure and surgical field.
Time Frame: From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).
|
The surgeons blinded to the treatment given to the patients will be asked to assess the quality of the surgical fiels using 1-4 likert scale
|
From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of respiratory adverse events
Time Frame: From admission to the post anesthesia care unit till discharge to the surgical department (expected average of 3 hours) and from admission to the surgical department till the time of home discharge (expected average of 5 days).
|
The incidence of respiratory events including- hypoxemia (defined as hemoglobin oxygen saturation lower then 92% while breathing room air), pneumonia (elevated body temperature and findings in chest x-ray), and the need for non invasive or invasive mechanical ventilation; will be assessed continuously during the post anesthesia care unit stay and on 6 hours intervals during the surgical department stay.
|
From admission to the post anesthesia care unit till discharge to the surgical department (expected average of 3 hours) and from admission to the surgical department till the time of home discharge (expected average of 5 days).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.
- Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.
- Matot I, Paskaleva R, Eid L, Cohen K, Khalaileh A, Elazary R, Keidar A. Effect of the volume of fluids administered on intraoperative oliguria in laparoscopic bariatric surgery: a randomized controlled trial. Arch Surg. 2012 Mar;147(3):228-34. doi: 10.1001/archsurg.2011.308. Epub 2011 Nov 21.
- Nsadi B, Gilson N, Pire E, Cheramy JP, Pincemail J, Scagnol I, Meurisse M, Defraigne JO, Detry O. Consequences of pneumoperitoneum on liver ischemia during laparoscopic portal triad clamping in a swine model. J Surg Res. 2011 Mar;166(1):e35-43. doi: 10.1016/j.jss.2010.10.033. Epub 2010 Nov 24.
- Fahy BG, Barnas GM, Nagle SE, Flowers JL, Njoku MJ, Agarwal M. Changes in lung and chest wall properties with abdominal insufflation of carbon dioxide are immediately reversible. Anesth Analg. 1996 Mar;82(3):501-5. doi: 10.1097/00000539-199603000-00013.
- Popescu WM, Bell R, Duffy AJ, Katz KH, Perrino AC Jr. A pilot study of patients with clinically severe obesity undergoing laparoscopic surgery: evidence for impaired cardiac performance. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):943-9. doi: 10.1053/j.jvca.2010.11.012. Epub 2011 Jan 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-12-9237-HB-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Morbid Obesity
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Rijnstate HospitalRecruiting
-
Laval UniversityCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie...Recruiting
-
University of WashingtonUnited States Department of DefenseWithdrawn
-
Helsinki University Central HospitalActive, not recruiting
-
IHU StrasbourgWithdrawnMorbid Obesity
Clinical Trials on Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
-
Thomas SchrickerMerck Sharp & Dohme LLCTerminatedHigh-Frequency Jet Ventilation | Vocal Cord ResectionCanada
-
Radboud University Medical CenterMerck Sharp & Dohme LLCUnknown
-
Merck Sharp & Dohme LLCCompletedNeuromuscular Blockade
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
University of California, San FranciscoMerck Sharp & Dohme LLCCompletedNeuromuscular BlockadeUnited States
-
Ziekenhuis Oost-LimburgMerck Sharp & Dohme LLCCompletedObesity | Surgical Conditions | Respiratory Function | Laparoscopic Gastric Bypass Surgery | Cerebral Tissue OxygenationBelgium
-
Technical University of MunichCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Radboud University Medical CenterMerck Sharp & Dohme LLCRecruitingQuality of Life | Postoperative Complications | Neuromuscular Blockade | Innate Inflammatory ResponseNetherlands