Neuromuscular Blockade Improves Surgical Conditions (NISCO)

March 18, 2013 updated by: Technical University of Munich
This study is designed to test the clinical hypothesis that a neuromuscular block improves surgical conditions, operation time, and post-operative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munic, Bavaria, Germany, 81675
        • Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NMB
muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy
Other: Neuromuscular blockade with rocuronium and reversal with sugammadex
Placebo Comparator: no NMB
no muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy
Other: Neuromuscular blockade with rocuronium and reversal with sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative patient-controlled analgesic demand for adequate pain control
Time Frame: Regular anesthesia time, approximately 1 hour
Regular anesthesia time, approximately 1 hour

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Manfred Blobner, MD, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 29, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimate)

May 8, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NISCO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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