Muscle Relaxation for Short Procedures - Full Text View

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 (Participant) 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:

Drug Information available for: Succinylcholine chloride Rocuronium bromide Rocuronium Sugammadex

U.S. FDA Resources

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) ]
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) ]
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 ]
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 ]
Measurement on an numeric ten point scale, the patients receive a questionaire
Patient Satisfaction [ Time Frame: 72 Hours after intervention ]
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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: 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


Responsible Party:	Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier:	NCT01902641 History of Changes
Other Study ID Numbers:	HSK001 2011_333N-MA ( Registry Identifier: medical faculty of the University Mannheim )
Study First Received:	July 9, 2013
Last Updated:	July 16, 2013

Keywords provided by Dr. Horst Schmidt Klinik GmbH:


succinylcholine rocuronium sugammadex Intubating Conditions short Procedures

Additional relevant MeSH terms:


Fasciculation Disease Pharyngitis Myalgia Pathologic Processes Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Pain Neurologic Manifestations	Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Neuromuscular Manifestations Anesthetics Rocuronium Succinylcholine Central Nervous System Depressants Physiological Effects of Drugs Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on July 13, 2017