Muscle Relaxation for Short Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier:
NCT01902641
First received: July 9, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Intubating Conditions
Fasciculations
Postoperative Myalgia
Patient Satisfaction
Sore Throat
Drug: Succinylcholine
Drug: Rocuronium/Sugammadex
Drug: Rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study

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


Secondary Outcome Measures:
  • Fasciculations [ Time Frame: After application of the neuromuscular blocking agent (after 3-5 min) ] [ Designated as safety issue: No ]

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

    0 = no fasciculations

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

  • Postoperative Myalgia (POM) [ 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


Other Outcome Measures:
  • Sore throat [ Time Frame: 72 hours after intervention ] [ Designated as safety issue: No ]
    Measurement on an numeric ten point scale, the patients receive a questionaire

  • Patient Satisfaction [ Time Frame: 72 Hours after intervention ] [ Designated as safety issue: No ]
    Measurement on a numeric ten point scale the patients receive a questionaire


Enrollment: 105
Study Start Date: October 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Succinylcholine
Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy.
Drug: Succinylcholine
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.
Active Comparator: Rocuronium/Sugammadex
Patient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.)
Drug: Rocuronium/Sugammadex
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.
Active Comparator: Rocuronium
Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy.
Drug: Rocuronium
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01902641

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

No publications provided

Responsible Party: Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT01902641     History of Changes
Other Study ID Numbers: HSK001, 2011_333N-MA
Study First Received: July 9, 2013
Last Updated: July 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Horst Schmidt Klinik GmbH:
succinylcholine
rocuronium
sugammadex
Intubating Conditions
short Procedures

Additional relevant MeSH terms:
Fasciculation
Pharyngitis
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Succinylcholine
Rocuronium
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 July 28, 2014