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Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996358
First Posted: November 27, 2013
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Grietje Beck, Dr. Horst Schmidt Klinik GmbH
  Purpose
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.

Condition Intervention
Intubating Conditions Postoperative Myalgia Patient Satisfaction Drug: Succinylcholine Drug: Rocuronium 0,3 Drug: Rocuronium 0,6

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Prof. Grietje Beck, Dr. Horst Schmidt Klinik GmbH:

Primary Outcome Measures:
  • Intubating Condition [ Time Frame: after induction of general anaesthesia (after 3-5 minutes) ]
    The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing


Secondary Outcome Measures:
  • Postoperative Myalgia [ Time Frame: 72 hours after intervention ]

    The severity of POM is measured by using a four-point-scale:

    0. no myalgia

    1. minor pain limited to one area of the body
    2. muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy
    3. generalized, severe or incapacitating discomfort


Other Outcome Measures:
  • Patient satisfaction [ Time Frame: 72 hours after intervention ]
    measurement on a numeric ten point scale


Estimated Enrollment: 150
Study Start Date: August 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Succinylcholine
Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy
Drug: Succinylcholine
Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.
Active Comparator: Rocuronium 0,3
Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Drug: Rocuronium 0,3
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Active Comparator: Rocuronium 0,6
Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Drug: Rocuronium 0,6
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 18 yr
  • scheduled for elective rigid bronchoscopy

Exclusion Criteria:

  • known neuromuscular disease
  • significant hepatic or renal dysfunction
  • family history of malignant hyperthermia
  • known allergy to one of the drugs used in this protocol
  • pregnancy or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996358


Locations
Germany
Dr. Horst Schmidt Klinik
Wiesbaden, Hessen, Germany, 65199
Sponsors and Collaborators
Dr. Horst Schmidt Klinik GmbH
Investigators
Study Chair: Grietje Beck, Prof Dr. Horst Schmidt Klinik
  More Information

Responsible Party: Prof. Grietje Beck, Professor Dr. med, Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT01996358     History of Changes
Other Study ID Numbers: HSK004
First Submitted: November 22, 2013
First Posted: November 27, 2013
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by Prof. Grietje Beck, Dr. Horst Schmidt Klinik GmbH:
Succinylcholine
Rocuronium
Rigid Bronchoscopy

Additional relevant MeSH terms:
Disease
Myalgia
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Anesthetics
Rocuronium
Succinylcholine
Central Nervous System Depressants
Physiological Effects of Drugs
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Neuromuscular Depolarizing Agents