Neuromuscular Blockade and Surgical Conditions

NCT01564576 | Unknown

• 1 other identifier: SHEBA-12-9237-HB-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Laparoscopic surgery; Anesthesiology; Neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• 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

  From abdominal insufflation with gas till the end of surgery (estimated time of 120 minutes).

Secondary Outcomes (1)

• Incidence of respiratory adverse events

  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).

Study Arms (2)

Conventional neuromuscular blockade

NO INTERVENTION

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.

Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)

Profound neuromuscular blockade

EXPERIMENTAL

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.

Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)

Interventions

Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion) DRUG

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.

Also known as: Rocuronium, Rocuronium bromide, sugammadex, Bridion

Conventional neuromuscular blockade; Profound neuromuscular blockade

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status Class I-III, scheduled to undergo elective sleeve gastrectomy

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (6)

• 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.

  PMID: 20124777 BACKGROUND

• 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.

  PMID: 22106246 BACKGROUND

• 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.

  PMID: 21176920 BACKGROUND

• 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.

  PMID: 8623951 BACKGROUND

• 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.

  PMID: 21232976 BACKGROUND

• 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.

  PMID: 17264722 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Rocuronium; Sugammadex

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Haim Berkenstadt, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haim Berkenstadt, MD

CONTACT

97235302966; haim.berkenstadt@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Anesthesiology

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 28, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

IL (1)