Back to resultsMuscle Relaxation for Short Procedures
Primary Purpose
Intubating Conditions, Fasciculations, Postoperative Myalgia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Succinylcholine
Rocuronium/Sugammadex
Rocuronium
Sponsored by
About this trial
This is an interventional treatment trial for Intubating Conditions focused on measuring succinylcholine, rocuronium, sugammadex, Intubating Conditions, short Procedures
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 Kliniken
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Succinylcholine
Rocuronium/Sugammadex
Rocuronium
Arm Description
Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy.
Patient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.)
Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy.
Outcomes
Primary Outcome Measures
Intubating condition
scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT01902641
First Posted
July 9, 2013
Last Updated
July 16, 2013
Sponsor
Dr. Horst Schmidt Klinik GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01902641
Brief Title
Muscle Relaxation for Short Procedures
Official Title
Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubating Conditions, Fasciculations, Postoperative Myalgia, Patient Satisfaction, Sore Throat
Keywords
succinylcholine, rocuronium, sugammadex, Intubating Conditions, short Procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Succinylcholine
Arm Type
Active Comparator
Arm Description
Patient received succinylcholine as a muscle relaxant(0.5 mg /kg)for induction of anaesthesia for rigid bronchoscopy.
Arm Title
Rocuronium/Sugammadex
Arm Type
Active Comparator
Arm Description
Patient received rocuronium (0.25 mg/ kg) as muscle relaxant for induction of anaesthesia for rigid bronchoscopy, at the end of procedure rocuronium was reversed with sugammadex (0.5mg/kg.)
Arm Title
Rocuronium
Arm Type
Active Comparator
Arm Description
Patients received rocuronium (0.25 mg /kg)as muscle relaxant for induction of anaesthesia for rigid bronchoscopy.
Intervention Type
Drug
Intervention Name(s)
Succinylcholine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium/Sugammadex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intubating condition
Description
scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting rigid bronchoscope, vocal cord position, and coughing
Time Frame
After induction of general anaesthesia (after 3-5 minutes)
Secondary Outcome Measure Information:
Title
Fasciculations
Description
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
Time Frame
After application of the neuromuscular blocking agent (after 3-5 min)
Title
Postoperative Myalgia (POM)
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
Other Pre-specified Outcome Measures:
Title
Sore throat
Description
Measurement on an numeric ten point scale, the patients receive a questionaire
Time Frame
72 hours after intervention
Title
Patient Satisfaction
Description
Measurement on a numeric ten point scale the patients receive a questionaire
Time Frame
72 Hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Kliniken Wiesbaden Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Horst Schmidt Kliniken
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Muscle Relaxation for Short Procedures
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