Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

Postoperative Myalgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966484
• Other study ID #: HSK003
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: July 29, 2014
• Start date: October 2013

Study information

• Verified date: July 2014
• 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 alternative is the application of low dose mivacurium, reversed with neostigmine. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), patient satisfaction and the postoperative performance with respiration exercise device for these two muscle relaxants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• 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: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubating Conditions
• Performance With Respiratory Exercise Device
• Postoperative Myalgia

Intervention

Drug:
• Succinylcholine
Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
• Mivacurium
Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.

Locations

Country	Name	City	State
Germany	Dr. Horst Schmidt Klinik GmbH	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	Patient satisfaction	Measurement on a numeric ten point scale (10=totally satisfied)	72 hours after intervention	No
Primary	Intubating condition	For measuring the intubation conditions the scoring system proposed for Good clinical Research Practice using the following variables is used: conditions of inserting the rigid bronchoscope, vocal cord position and coughing	After induction of general anaesthesia (after 3-5 minutes)	No
Secondary	Postoperative Myalgia	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
Secondary	postintervention performance with a expiration exercise device	The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.	72 hours after intervention	No