Neuromuscular Blockade Improves Surgical Conditions
Condition: Neuromuscular Blockade
Study type: Interventional

Summary: 
      This study is designed to test the clinical hypothesis that a neuromuscular block improves
      surgical conditions, operation time, and post-operative pain.
    

Detailed description: 
      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.
    

Intervention name(s): Neuromuscular blockade with rocuronium and reversal with sugammadex
Intervention type(s): Other
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuromuscular blockade; post-operative pain; post-operative pulmonary function