Muscle Relaxation for Short Procedures

NCT01902641 | Completed

• 2 other identifiers: HSK0012011_333N-MA
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubating Conditions; Fasciculations; Postoperative Myalgia; Patient Satisfaction; Sore Throat

Keywords

succinylcholine; rocuronium; sugammadex; Intubating Conditions; short Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fasciculations

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

• Postoperative Myalgia (POM)

  72 Hours after Intervention

Other Outcomes (2)

• Sore throat

  72 hours after intervention

• Patient Satisfaction

  72 Hours after intervention

Study Arms (3)

Succinylcholine

ACTIVE COMPARATOR

Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy.

Drug: Succinylcholine

Rocuronium/Sugammadex

ACTIVE COMPARATOR

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

Rocuronium

ACTIVE COMPARATOR

Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy.

Drug: Rocuronium

Interventions

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.

Succinylcholine

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/Sugammadex

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.

Rocuronium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 yr
• scheduled for elective rigid bronchoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

Dr. Horst Schmidt Kliniken

Wiesbaden, 65199, Germany

Location

MeSH Terms

Conditions

Fasciculation; Patient Satisfaction; Pharyngitis

Interventions

Succinylcholine; Rocuronium; Sugammadex

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Grietje Beck, Prof

  Dr. Horst Schmidt Kliniken Wiesbaden Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 18, 2013
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

DE (1)