Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

Not Applicable

Completed

• Conditions: Performance With Respiratory Exercise Device; Postoperative Myalgia; Intubating Conditions
• Interventions: Drug: Mivacurium; Drug: Succinylcholine

• Registration Number: NCT01966484
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-21
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mivacurium	Mivacurium	Patients receive mivacurium (0,08mg/kg) as a muscle relaxant after induction of general anaesthesia for rigid bronchoscopy. At the end of the procedure and a twitch of 25% mivacurium was reversed with neostigmine (50 microg/kg) and atropin (10 microg/kg)
Succinylcholine	Succinylcholine	Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy.

Primary Outcome Measures

Name	Time	Method
Intubating condition	After induction of general anaesthesia (after 3-5 minutes)	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

Secondary Outcome Measures

Name	Time	Method
Postoperative Myalgia	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
postintervention performance with a expiration exercise device	72 hours after intervention	The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.

Trial Locations

Locations (1)

Dr. Horst Schmidt Klinik GmbH; 🇩🇪 Wiesbaden, Germany