Back to resultsLow Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy
Primary Purpose
Intubating Conditions, Performance With Respiratory Exercise Device, Postoperative Myalgia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Succinylcholine
Mivacurium
Sponsored by
About this trial
This is an interventional treatment trial for Intubating Conditions focused on measuring Succinylcholine, Mivacurium, Rigid Bronchoscopy, Intubating conditions, Short Procedure
Eligibility Criteria
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
Sites / Locations
- Dr. Horst Schmidt Klinik GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Succinylcholine
Mivacurium
Arm Description
Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy.
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
postintervention performance with a expiration exercise device
The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.
Full Information
NCT ID
NCT01966484
First Posted
October 17, 2013
Last Updated
July 29, 2014
Sponsor
Dr. Horst Schmidt Klinik GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01966484
Brief Title
Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubating Conditions, Performance With Respiratory Exercise Device, Postoperative Myalgia
Keywords
Succinylcholine, Mivacurium, Rigid Bronchoscopy, Intubating conditions, Short Procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Succinylcholine
Arm Type
Active Comparator
Arm Description
Patient receive succinylcholine as a muscle relaxant (0,5mg/kg) after induction of general anaesthesia for rigid bronchoscopy.
Arm Title
Mivacurium
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Succinylcholine
Other Intervention Name(s)
Mivacurium, Rigid Bronchoscopy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mivacurium
Other Intervention Name(s)
Succinylcholine, Rigid Bronchoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intubating condition
Description
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
Time Frame
After induction of general anaesthesia (after 3-5 minutes)
Secondary Outcome Measure Information:
Title
Postoperative Myalgia
Description
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
Time Frame
72 hours after intervention
Title
postintervention performance with a expiration exercise device
Description
The performance with a respiration exercise device, which measures the expirational volume, before and after intervention.
Time Frame
72 hours after intervention
Other Pre-specified Outcome Measures:
Title
Patient satisfaction
Description
Measurement on a numeric ten point scale (10=totally satisfied)
Time Frame
72 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grietje Beck, Prof
Organizational Affiliation
Dr. Horst Schmidt Klinik GmbH 65199 Wiesbaden, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Horst Schmidt Klinik GmbH
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
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Low Dose Mivacurium vs. Low Dose Succinylcholine for Rigid Bronchoscopy
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