Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier:
NCT01966484
First received: October 17, 2013
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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 Intervention
Intubating Conditions
Performance With Respiratory Exercise Device
Postoperative Myalgia
Drug: Succinylcholine
Drug: Mivacurium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dr. Horst Schmidt Klinik GmbH:

Primary Outcome Measures:
  • Intubating condition [ Time Frame: After induction of general anaesthesia (after 3-5 minutes) ] [ Designated as safety issue: No ]
    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:
  • Postoperative Myalgia [ Time Frame: 72 hours after intervention ] [ Designated as safety issue: No ]

    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

  • postintervention performance with a expiration exercise device [ Time Frame: 72 hours after intervention ] [ Designated as safety issue: No ]
    The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.


Other Outcome Measures:
  • Patient satisfaction [ Time Frame: 72 hours after intervention ] [ Designated as safety issue: No ]
    Measurement on a numeric ten point scale (10=totally satisfied)


Estimated Enrollment: 100
Study Start Date: October 2013
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Succinylcholine
  • 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
  • Mivacurium
  • Rigid Bronchoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT01966484     History of Changes
Other Study ID Numbers: HSK003
Study First Received: October 17, 2013
Last Updated: July 29, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Succinylcholine
Mivacurium
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Nondepolarizing Agents

ClinicalTrials.gov processed this record on September 18, 2014