An examination of which type of medicine (rocuronium or remifentanil) is better concerning placement of a tube in trachea in elderly patients under going anesthesia
Phase 1
- Conditions
- The aim of this study is to determine the effect on intubating conditionsand laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age = 80 years.MedDRA version: 21.1Level: LLTClassification code 10002323Term: Anesthesia generalSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-004121-25-DK
- Lead Sponsor
- Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- Age = 80
- Scheduled for elective operations (expected duration of anesthesia >
1 hour) under general anesthesia with intubation
- American Society of Anesthesiologists physical status classification
(ASA) I to III
- Informed consent (see appendix 1)
- 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 74
Exclusion Criteria
- Neuromuscular disease
- Known allergy to rocuronium, remifentanil or sugammadex
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to determine the effect on intubating conditions<br>and laryngeal morbidity after either rocuronium 0.6 mg/kg or<br>remifentanil 2 µg/kg in patients with age = 80 years. ;Secondary Objective: The aim of this study is to determine the effect on intubating conditions<br>and laryngeal morbidity after either rocuronium 0.6 mg/kg or<br>remifentanil 2 µg/kg in patients with age = 80 years. The aim of this<br>study is to determine the effect on intubating conditions and laryngeal<br>morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in<br>patients with age = 80 years. ;Primary end point(s): The primary outcome is the occurrence of excellent intubating conditions<br>2 minutes after administration of 0.6 mg/kg rocuronium or 2 µg/kg<br>remifentanil, scored according to Fuchs-Buder et al. <br>;Timepoint(s) of evaluation of this end point: It will be examined 2 minutes after bolus injection
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Subjective side effects of laryngoscope<br>Amount of epinephrine or metaoxedrine administered<br>Intubation Difficulty Score ;Timepoint(s) of evaluation of this end point: During the operation