Muscle Relaxation for Short Procedures

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902641
• Other study ID #: HSK001
• Secondary ID: 2011_333N-MA
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: July 16, 2013
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Fasciculation
• Fasciculations
• Intubating Conditions
• Patient Satisfaction
• Postoperative Myalgia
• Sore Throat

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Dr. Horst Schmidt Kliniken	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sore throat	Measurement on an numeric ten point scale, the patients receive a questionaire	72 hours after intervention	No
Other	Patient Satisfaction	Measurement on a numeric ten point scale the patients receive a questionaire	72 Hours after intervention	No
Primary	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)	No
Secondary	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)	No
Secondary	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	No