A Comparison of Rocuronium 0.6 mg/kg and Remifentanil 2 µg/kg in Elderly Patients Over 80 Years

Study Overview
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Brief Summary
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The number of elderly patients above 80 years is increasing and a large proportion of these patients will require surgery and anesthesia. During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. There is a risk of residual neuromuscular block when using NMBAs like rocuronium. Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen. It is unknown which is superior concerning intubating conditions in elderly patients. Therefore, the aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.

Detailed Description
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The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia within the next decades. Elderly patients are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia. During anesthesia neuromuscular blocking agents (NMBA) are administered to facilitate intubating conditions and reduce the trauma to the larynx and vocal cords. Studies suggests that avoidance of neuromuscular blocking agents (NMBAs) increases the risk of difficult tracheal intubation and leads to impaired intubating conditions with direct laryngoscopy. Furthermore, avoidance of NMBA significantly increases the risk of upper airway discomfort or injury. Even low doses of rocuronium may be associated with a significant improvement of intubating conditions. Remifentanil is a fentanyl analogue commonly used for induction since it also facilitates intubation. There is no risk of residual neuromuscular block, nonetheless circulatory side effects have been seen. The possible benefit in this trial is to investigate whether rocuronium 0.6 mg/kg or remifentanil 2 µg/kg provides best intubating conditions in the elderly. This may result in different intubating difficulty scores between the two groups of elderly patients. The results may help to detect the optimal method for intubation of the trachea in elderly patients. The aim of this study is to determine the effect on intubating conditions and laryngeal morbidity after either rocuronium 0.6 mg/kg or remifentanil 2 µg/kg in patients with age ≥ 80 years. The hypothesis of this study is that rocuronium 0.6 mg/kg provides a higher proportion with excellent intubating conditions compared to remifentanil 2 µg/kg.

Official Title
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A Single-blinded Multicenter Randomized Study Comparing Intubating Conditions After Either Rocuronium 0.6 mg/kg or Remifentanil 2 µg/kg in Elderly Patients

Conditions
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Neuromuscular Blockade, Intubation Complication, Anesthesia

Intervention / Treatment
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* Drug: Rocuronium 0.6 mg/kg
* Drug: Remifentanil 2 µg/kg


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Neuromuscular disease Known allergy to rocuronium, remifentanil or sugammadex Rapid sequence induction

Ages Eligible for Study
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Minimum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group receiving rocuronium at induction<br>Rocuronium 0,6 mg/kg at induction | Drug: Rocuronium 0.6 mg/kg<br>* Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil<br>|
| Active Comparator: Group receiving remifentanil at induction<br>Remifentanil 2 μg/kg at induction | Drug: Remifentanil 2 µg/kg<br>* Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of intubating conditions ad modum Fuchs-Buder et al | Occurrence of excellent intubating conditions 2 minutes after start of administration of 0.6 mg/kg rocuronium or 2 µg/kg remifentanil, scored according to Fuchs-Buder et al. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality is listed as poor. | 2 minutes after start of administration of trial medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective side effects of laryngoscopy | After 24 hours patients are asked about hoarseness and sore throat. The patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale. | 24 hours postoperatively and 3 days postoperatively | 
| Dose of ephedrine or dose of metaoxedrine administered | If ephedrine and/or metaoxedrine is administered in the time period from induction until the patient is ready to be positioned for surgery it will be noted in the CRF. The amount administered will also be noted in the CRF. Changes in blood pressure are treated according to local guidelines. | From induction until the patient is ready to be positioned for surgery, ranging from 5 minutes up to 1 hour. | 
| Intubating conditions according to IDS | Another way of rating intubating conditions are by an intubating difficulty scale (Table 2) (20) 2 minutes after injection of rocuronium/remifentanil. The investigator performing the intubation will be handed the CRF where he/she will fill out Table 2. Furthermore, investigator will note if a stylet or video laryngoscope has been used. | 2 minutes after start of administration of trial medication |