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Completed

NCT Number: NCT01966484

Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

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.

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Key information

Conditions

Intubating Conditions Performance With Respiratory Exercise Device Postoperative Myalgia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Horst Schmidt Klinik GmbH

Wiesbaden, 65199, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Succinylcholine

Drug

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

Mivacurium

Drug

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

Primary outcomes

  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 outcomes

  1. Postoperative Myalgia

    Time frame: 72 hours after intervention

    The severity of POM was measured using a four point scale:

    0=no myalgia

    • minor pain limited to one area of the body
    • muscle pain or stiffness noticed spontaneously by the patient, which may have required analgesic therapy
    • 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 outcomes

  1. Patient satisfaction

    Time frame: 72 hours after intervention

    Measurement on a numeric ten point scale (10=totally satisfied)

Sponsors and collaborators

Lead sponsor

Dr. Horst Schmidt Klinik GmbH

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Oct 21, 2013
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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