Neuromuscular Blockade and Surgical Conditions (Sugamadex)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Haim Berkenstadt, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01564576
First received: March 15, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Morbid Obesity
Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Influence of the Magnitude of Neuromuscular Blockade on the Surgical Conditions During Laparoscopic Sleeve Gastrectomy

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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 [ 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). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
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 Name: Rocuronium, Rocuronium bromide, sugammadex, Bridion
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.
Drug: Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)
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 Name: Rocuronium, Rocuronium bromide, sugammadex, Bridion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564576

Contacts
Contact: Haim Berkenstadt, MD 97235302966 haim.berkenstadt@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel
Contact: Haim Berkenstadt, MD    97235302966 ext 2966    haim.berkenstadt@sheba.health.gov.il   
Principal Investigator: Haim Berkenstadt, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Haim Berkenstadt, MD Sheba Medical Center
  More Information

Publications:

Responsible Party: Dr. Haim Berkenstadt, Chairman of Anesthesiology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01564576     History of Changes
Other Study ID Numbers: SHEBA-12-9237-HB-CTIL
Study First Received: March 15, 2012
Last Updated: March 27, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Laparoscopic surgery
Anesthesiology
Neuromuscular blockade

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bromides
Rocuronium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014