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OpenTrials
Completed

NCT Number: NCT01902641

Muscle Relaxation for Short Procedures

Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as patient satisfaction for these two muscle relaxants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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 (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received succinycholine according to the study group.

Rocuronium/Sugammadex

Drug

Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium/sugammadex according to the study group.

Rocuronium

Drug

Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium according to the study group.

Primary outcomes

  1. Intubating condition

    Time frame: After induction of general anaesthesia (after 3-5 minutes)

    scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing

Secondary outcomes

  1. Fasciculations

    Time frame: After application of the neuromuscular blocking agent (after 3-5 min)

    Fasciculations were graded by the investigator on the following four-point scale

    0 = no fasciculations

    • = mild, fine fasciculations of the eyes, neck, face or fingers, without limb movement
    • = moderate fasciculations occurring at more than two sites, or obvious limb movement
    • = vigorous or severe, sustained and widespread fasciculations in the trunk and limbs
  2. Postoperative Myalgia (POM)

    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

Other outcomes

  1. Sore throat

    Time frame: 72 hours after intervention

    Measurement on an numeric ten point scale, the patients receive a questionaire

  2. Patient Satisfaction

    Time frame: 72 Hours after intervention

    Measurement on a numeric ten point scale the patients receive a questionaire

Sponsors and collaborators

Lead sponsor

Dr. Horst Schmidt Klinik GmbH

Industry

Registry information

Official study title

Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2013
Registry last updated
Jul 18, 2013

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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