Neuromuscular Blockade Improves Surgical Conditions

Not Applicable

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Other: Neuromuscular blockade with rocuronium and reversal with sugammadex

• Registration Number: NCT00895778
• Lead Sponsor: Technical University of Munich

Brief 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2010-12
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no NMB	Neuromuscular blockade with rocuronium and reversal with sugammadex	no muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy
NMB	Neuromuscular blockade with rocuronium and reversal with sugammadex	muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Postoperative patient-controlled analgesic demand for adequate pain control	Regular anesthesia time, approximately 1 hour

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munic, Bavaria, Germany