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Neuromuscular Blockade and Surgical Conditions (Sugamadex)

Primary Purpose

Morbid Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Laparoscopic surgery, Anesthesiology, Neuromuscular blockade

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional neuromuscular blockade

Profound neuromuscular blockade

Arm Description

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.

Outcomes

Primary Outcome Measures

Subjective surgeon feedback on the exposure and surgical field.
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

Secondary Outcome Measures

Incidence of respiratory adverse events
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.

Full Information

First Posted
March 15, 2012
Last Updated
March 27, 2012
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01564576
Brief Title
Neuromuscular Blockade and Surgical Conditions
Acronym
Sugamadex
Official Title
The Influence of the Magnitude of Neuromuscular Blockade on the Surgical Conditions During Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study is to prospectively assess whether deep neuromuscular blockade (NMB) (zero response to train of four and a post tetanic count of no more than 10 responses using a nerve stimulator monitoring) until 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 NMBwith sugammadex (bridion®) will enable quick and full reversal of relaxation and fewer postoperative respiratory events as compared to neostigmine (Prostigmin®, Vagostigmin®)reversal. Participants will be followed for the duration of hospital stay, an expected average of 7 days.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Laparoscopic surgery, Anesthesiology, Neuromuscular blockade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional neuromuscular blockade
Arm Type
No Intervention
Arm Description
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.
Arm Title
Profound neuromuscular blockade
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
Other Intervention Name(s)
Rocuronium, Rocuronium bromide, sugammadex, Bridion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective surgeon feedback on the exposure and surgical field.
Description
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
Time Frame
From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).
Secondary Outcome Measure Information:
Title
Incidence of respiratory adverse events
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haim Berkenstadt, MD
Phone
97235302966
Email
haim.berkenstadt@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Berkenstadt, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haim Berkenstadt, MD
Phone
97235302966
Ext
2966
Email
haim.berkenstadt@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Haim Berkenstadt, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20124777
Citation
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.
Results Reference
background
PubMed Identifier
22106246
Citation
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.
Results Reference
background
PubMed Identifier
21176920
Citation
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.
Results Reference
background
PubMed Identifier
8623951
Citation
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.
Results Reference
background
PubMed Identifier
21232976
Citation
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.
Results Reference
background
PubMed Identifier
17264722
Citation
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.
Results Reference
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Neuromuscular Blockade and Surgical Conditions

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