Neuromuscular Blocking Agents in the Elderly

Completed

Conditions: Elective Surgery

Interventions: Drug: Rocuronium

Registration Number: NCT03857750

Lead Sponsor: Rigshospitalet, Denmark

Brief Summary: The number of elderly patients (\>80 years) is increasing and a large proportion of these patients will require surgery and anaestheasia within the next decades.

During anaesthesia NMBAs are used to facilitate tracheal intubation, from former studies it is reported that elderly patients are more sensitive towards muscle relaxants.

It is unknown if there are differences in onset times of NMBAs between younger patients and elderly.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patiens \>80 years. The hypothesis of this study is that rocuronium administered in elderly patients (\>80 years) has a longer onset time compared to younger patients.

Detailed Description: 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 as for example neuromuscular blocking agents (NMBA).

During anesthesia NMBAs are used to facilitate tracheal intubation, establish muscle relaxation and suppress reflexes during surgery. Elderly patients are more sensitive towards muscle relaxants. In addition studies have reported prolonged duration of NMBAs and an observational study found that elderly patients are more prone to experience residual neuromuscular blockade in the post anesthesia care unit. However, most studies have been conducted in elderly below 80 years.

It is unknown if there are differences in onset times of NMBAs e.g. rocuronium, mivacurium and cisatracurium between younger patients and elderly. Onset time for NMBAs in the elderly is of importance since it may influence intubating conditions, especially during rapid sequence induction. For example it is unknown in the elderly if an increased dose of NMBA reduces the onset time. There remains a need for studies investigating the optimal dose for facilitating intubation in the elderly, both during rapid sequence induction and during elective procedures.

The aim of this study is to determine the onset time, duration of action and effect on intubating conditions for rocuronium 0.6 mg/kg in patients aged 18-40 years and in patients with age \> 80 years. The hypothesis of this study is that rocuronium administered in elderly patients (\>80 years) has a longer onset in the elderly compared to younger patients.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

Inclusion Criteria

Patients > 18 years old
Informed consent
Scheduled for elective surgery (>1 hour) under general anaesthesia with intubation and use of rocuronium.
American Society of Anaesthesiologists (ASA) physical status classification I to III
Can read and understand Danish

Exclusion Criteria

Known allergy to rocuronium
Neuromuscular disease that may interfere with neuromuscular data
Indication for rapid sequence induction

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly (>80 years)	Rocuronium	Patients planned for elective surgery above 80 years
Younger (18-40 years)	Rocuronium	Patients planned for elective surgery between 18-40 years

Primary Outcome Measures

Name	Time	Method
Onset Time	Day 0, after induction of anesthesia	The time from the end of rocuronium injection to train-of-four (TOF) count of 0 monitored by acceleromyography. The ulnar nerve was stimulated during the monitoring.

Secondary Outcome Measures

Name	Time	Method
Duration of Action	Day 0, after induction of anesthesia	Time from end of rocuronium injection to TOF ratio \>0.9. When the ratio between the first and last stimulation in TOF is above 90 %.
Comparing Intubating Conditions in the Two Groups	Day 0, after induction of anesthesia	90 seconds after induction the conditions are rated by the Intubating Difficulty Scale (IDS). Easy is defined as IDS of 0. Slight is defined as IDS of 1 to 5 Moderate/Major is defined as \>5