Muscle Relaxation for Short Procedures

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Sore Throat; Intubating Conditions; Postoperative Myalgia; Fasciculations
• Intervention / Treatment: Drug: Succinylcholine; Drug: Rocuronium/Sugammadex; Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wiesbaden, Germany, 65199
    • Dr. Horst Schmidt Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubating condition	scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing	After induction of general anaesthesia (after 3-5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasciculations	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	After application of the neuromuscular blocking agent (after 3-5 min)
Postoperative Myalgia (POM)	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	72 Hours after Intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore throat	Measurement on an numeric ten point scale, the patients receive a questionaire	72 hours after intervention
Patient Satisfaction	Measurement on a numeric ten point scale the patients receive a questionaire	72 Hours after intervention

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH
• Investigators: Study Chair: Grietje Beck, Prof, Dr. Horst Schmidt Kliniken Wiesbaden Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 9, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Estimate): July 18, 2013
• Last Update Submitted That Met QC Criteria: July 16, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: rocuronium; succinylcholine; sugammadex; Intubating Conditions; short Procedures
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neuromuscular Manifestations; Myalgia; Disease; Pharyngitis; Fasciculation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Rocuronium; Succinylcholine
• Other Study ID Numbers: HSK001; 2011_333N-MA (Registry Identifier: medical faculty of the University Mannheim)