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Neuromuscular Blockade Improves Surgical Conditions (NISCO)

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ClinicalTrials.gov Identifier: NCT00895778
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : March 19, 2013
Sponsor:
Information provided by:
Technische Universität München

April 29, 2009
May 8, 2009
March 19, 2013
March 2009
December 2010   (Final data collection date for primary outcome measure)
Postoperative patient-controlled analgesic demand for adequate pain control [ Time Frame: Regular anesthesia time, approximately 1 hour ]
Same as current
Complete list of historical versions of study NCT00895778 on ClinicalTrials.gov Archive Site
  • Incidence of intraoperative muscle movements
  • Incision-to-suture-time
  • Surgeon's and anesthesiologist's opinion about the operating conditions assessed by a visual analogue scale (VAS)
  • Postoperative pulmonary function
Same as current
Not Provided
Not Provided
 
Neuromuscular Blockade Improves Surgical Conditions
Neuromuscular Blockade Improves Surgical Conditions
This study is designed to test the clinical hypothesis that a neuromuscular block improves surgical conditions, operation time, and post-operative pain.

Muscle relaxants are part of a balanced anesthesia regimen. So far, evidence is given that a neuromuscular block improves intubating conditions and protects against laryngeal morbidity. The doctrine, however, that a neuromuscular block improves surgical conditions and consequently patient care, is lacking any evidence based on clinical trials.

This study, therefore, is designed to test the clinically hypothesis that a neuromuscular block improves surgical conditions. One major problem in such a setting, however, is that it is difficult to measure what "good" or "better" surgical conditions are. We therefore suggest surrogates to test the hypothesis. The primary endpoint is the postoperative patient-controlled analgesic demand for adequate pain control. The secondary endpoints are the incidence of intraoperative events reflecting muscle relaxation during anesthesia, defined as movements of limbs or the abdominal wall, or as breathing, bucking or coughing against the ventilator, the incision-to-suture-time, the surgeon's and the anesthesiologist's opinion about the operating conditions assessed by a visual analogue scale (VAS), and the postoperative pulmonary function.

We will investigate patients scheduled for elective laparoscopic cholecystectomy under general anesthesia. The study is designed to allow optimal conditions to test the hypothesis. This results in two experimental groups representing two established anesthesia regimen (n = 25 per group). Patients of the group "no NMB" are anesthetized without any muscle relaxant. Patients of the group "NMB" are anesthetized using the same drugs as the "no NMB" group but additionally receive a neuromuscular blocking agent to induce a deep neuromuscular block from induction of anesthesia until skin suture.

Anesthesia will be induced with propofol and fentanyl. Airway will be managed using a ProSeal® Laryngeal mask which allows insertion of a gastric tube. Anesthesia will be maintained with desflurane inhalation and remifentanil infusion under BIS control. The group NMB will receive rocuronium to maintain a deep neuromuscular block (T2 < 2) until the fascia is sutured. Neuromuscular block will be reversed with sugammadex. Saline boli will be applied to the patients of the group "no NMB" every 25-35 min in order to keep the anesthesiologist blinded.

Post-operatively, in 15 min intervals during their stay and before discharge from the recovery room patients' level of consciousness will be assessed, and the updated Aldrete score will be obtained. In co-operative patients a 5-s head lift test, a 5-s arm lift test, swallowing of 20 ml water, and 5-s eye opening test will be performed. To achieve pain control, a microprocessor-controlled PCA system will be used.

The patients' respiratory function will be assessed before induction of anesthesia, 5 minutes after tracheal extubation, 30 minutes later in the postanesthesia care unit, and six hours later on the ward using a portable using spirometry device.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuromuscular Blockade
Other: Neuromuscular blockade with rocuronium and reversal with sugammadex
  • Experimental: NMB
    muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy
    Intervention: Other: Neuromuscular blockade with rocuronium and reversal with sugammadex
  • Placebo Comparator: no NMB
    no muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy
    Intervention: Other: Neuromuscular blockade with rocuronium and reversal with sugammadex

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
Not Provided
December 2012
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Patients ASA physical status I - III
  • Patients between 18 and 64 years
  • Patients scheduled for general anesthesia with intubation using rocuronium
  • Patients having given informed consent to the study

Exclusion Criteria:

  • Anatomic and functional malformations with expected difficult intubation
  • Known or suspected neuromuscular disease
  • Significant hepatic or renal dysfunction
  • Known or suspected history or family history of disposition to malignant hyperthermia
  • Known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
  • Use of drugs that interfere with muscle relaxants
  • Patients, included in another trial within the last 30 days
  • Patients, with legal guidant
  • Patients with contraindication towards the use of Sugammadex, neostigmine or glycopyrrolate
  • Patients, which have already participated in a sugammadex trial
  • Pregnant women (exclusion of pregnancy: postmenopausal status, negative beta-HCG screen, status post tubal ligation)
  • Breastfeeding women
  • Patients who are unable to understand or successfully administer a patient- controlled-analgesia (PCA) device
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00895778
NISCO
Yes
Not Provided
Not Provided
Not Provided
Technische Universität München
Not Provided
Principal Investigator: Manfred Blobner, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Technische Universität München
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP