A randomized study comparing two types of muscle relaxants regarding the influence on tracheal intubation during anaesthesia in elderly patients (= 80 years old)
- Conditions
- The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age = 80 years.MedDRA version: 23.1Level: LLTClassification code 10051079Term: Orthopedic procedureSystem Organ Class: 100000004865MedDRA version: 20.0Level: LLTClassification code 10000082Term: Abdominal pain generalisedSystem Organ Class: 100000004856Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2020-005384-31-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
-Age = 80
-Scheduled for surgery under general anesthesia with indication for rapid sequence induction
-American Society of Anesthesiologists physical status classification (ASA) I to IV
-Informed consent (see appendix 1)
-Body mass index (BMI) < 35 kg/m2
-Read and understand Danish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
-Neuromuscular disease
-Known allergy to rocuronium and/or suxamethonium
-Known hyperkalemia > 5 mM
-Previous malignant hyperthermia
-Known homozygote plasmacholinesterase gene mutation variant a or s
-Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) < 30
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method