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Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

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ClinicalTrials.gov Identifier: NCT01966484
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A alternative is the application of low dose mivacurium, reversed with neostigmine. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), patient satisfaction and the postoperative performance with respiration exercise device for these two muscle relaxants.

Condition or disease Intervention/treatment
Intubating Conditions Performance With Respiratory Exercise Device Postoperative Myalgia Drug: Succinylcholine Drug: Mivacurium

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2013
Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Succinylcholine
Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy.
Drug: Succinylcholine
Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
Other Names:
  • Mivacurium
  • Rigid Bronchoscopy
Active Comparator: Mivacurium
Patients receive mivacurium (0,08mg/kg) as a muscle relaxant after induction of general anaesthesia for rigid bronchoscopy. At the end of the procedure and a twitch of 25% mivacurium was reversed with neostigmine (50 microg/kg) and atropin (10 microg/kg)
Drug: Mivacurium
Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
Other Names:
  • Succinylcholine
  • Rigid Bronchoscopy


Outcome Measures

Primary Outcome Measures :
  1. Intubating condition [ Time Frame: After induction of general anaesthesia (after 3-5 minutes) ]
    For measuring the intubation conditions the scoring system proposed for Good clinical Research Practice using the following variables is used: conditions of inserting the rigid bronchoscope, vocal cord position and coughing


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

    The severity of POM was measured 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

  2. postintervention performance with a expiration exercise device [ Time Frame: 72 hours after intervention ]
    The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.


Other Outcome Measures:
  1. Patient satisfaction [ Time Frame: 72 hours after intervention ]
    Measurement on a numeric ten point scale (10=totally satisfied)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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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): NCT01966484


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

Responsible Party: Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT01966484     History of Changes
Other Study ID Numbers: HSK003
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

Keywords provided by Dr. Horst Schmidt Klinik GmbH:
Succinylcholine
Mivacurium
Rigid Bronchoscopy
Intubating conditions
Short Procedure

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