Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy

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.

Study Overview

• Status: Completed
• Conditions: Intubating Conditions; Performance With Respiratory Exercise Device; Postoperative Myalgia
• Intervention / Treatment: Drug: Succinylcholine; Drug: Mivacurium

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Wiesbaden, Germany, 65199
    • Dr. Horst Schmidt Klinik GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Succinylcholine; Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy.	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.; Other Names: Mivacurium; Rigid Bronchoscopy
Active Comparator: 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)	Drug: 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.; Other Names: Succinylcholine; Rigid Bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Measurement on a numeric ten point scale (10=totally satisfied)	72 hours after intervention

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH
• Investigators: Study Chair: Grietje Beck, Prof, Dr. Horst Schmidt Klinik GmbH 65199 Wiesbaden, Germany

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Succinylcholine; Mivacurium; Rigid Bronchoscopy; Intubating conditions; Short Procedure
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Depolarizing Agents; Succinylcholine; Mivacurium
• Other Study ID Numbers: HSK003