Back to resultsComparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
Primary Purpose
Intubating Conditions, Postoperative Myalgia, Patient Satisfaction
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Succinylcholine
Rocuronium 0,3
Rocuronium 0,6
Sponsored by
About this trial
This is an interventional treatment trial for Intubating Conditions focused on measuring Succinylcholine, Rocuronium, Rigid Bronchoscopy
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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Succinylcholine
Rocuronium 0,3
Rocuronium 0,6
Arm Description
Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy
Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Outcomes
Primary Outcome Measures
Intubating Condition
The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: conditions of inserting the rigid bronchoscope, vocal cord position and coughing
Secondary Outcome Measures
Postoperative Myalgia
The severity of POM is measured by 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
NCT01996358
First Posted
November 22, 2013
Last Updated
April 3, 2017
Sponsor
Dr. Horst Schmidt Klinik GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01996358
Brief Title
Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
Official Title
Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Suspended
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH
4. Oversight
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 aof rocuronium, reversed by 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, Postoperative Myalgia, Patient Satisfaction
Keywords
Succinylcholine, Rocuronium, Rigid Bronchoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Succinylcholine
Arm Type
Active Comparator
Arm Description
Succinylcholine 0,5mg/kg as muscle relaxant during induction of anaesthesia for rigid bronchoscopy
Arm Title
Rocuronium 0,3
Arm Type
Active Comparator
Arm Description
Rocuronium 0,3 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Arm Title
Rocuronium 0,6
Arm Type
Active Comparator
Arm Description
Rocuronium 0,6 mg/kg during induction of anaesthesia for rigid bronchoscopy. At the end of procedure 2mg/kg sugammadex for reversal of neuromuscular block are applied.
Intervention Type
Drug
Intervention Name(s)
Succinylcholine
Intervention Description
Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.
Intervention Type
Drug
Intervention Name(s)
Rocuronium 0,3
Intervention Description
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Intervention Type
Drug
Intervention Name(s)
Rocuronium 0,6
Intervention Description
General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
Primary Outcome Measure Information:
Title
Intubating Condition
Description
The intubating conditions will be measured using the scoring system proposed for Good Clinical Research Practice using the following variables: 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 is measured by 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
Patient satisfaction
Description
measurement on a numeric ten point scale
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 Klinik
Official's Role
Study Chair
Facility Information:
Facility Name
Dr. Horst Schmidt Klinik
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
We'll reach out to this number within 24 hrs