Evaluation of Duration of Curarisation (Surgical Efficacy) and Pharmacokinetics of Neuromuscular Block After a Single Dose of Rocuronium in Geriatric Patients (Age ≥ 80 Years ) Compared to a Younger Population (Age < 50 Years).
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Total time of neuromuscular block
Study Overview
Brief Summary
Elderly people, especially geriatric patients, account for a growing share of patients receiving anesthesia.
In patients over 75 years of age the annual rate of anesthesia represents 16.8 / 100 inhabitants for women and 19.6 / 100 for men. It is a growing population, but also the most fragile population with a mortality amounting to 44.4 / 10000 anesthesia. After 85 years, one out of every two patients is ASA 3 or older.
The first cause of death related to anesthesia today remains respiratory complications, particularly infectious.
This is a major public health issue right now. The studies on the use of curare and particularly rocuronium are old and did not study a population of elderly people (with an average age of 70 years). Several studies show an increase in the duration of neuromuscular blockade in patients older than 70 years irrespective of any renal failure, with sometimes persistent curarizations more than 2h after a single dose. But no study to date has studied the duration of deep-intensity neuromuscular block (TOF).
Detailed Description
Scientific justification Elderly patients, especially geriatric patients, represent an increasing percentage of patients receiving anesthesia. Thus, among the population over 75 years old, the annual rate of anesthesia represents 16.8 / 100 inhabitants. women and 19.6 / 100 in men. This is a growing population, but also the most fragile population with a mortality amounting to 44.4 / 10000 anesthesia. After 85 years, one out of every two anesthetized patients is ASA 3 or higher. The first cause of mortality linked to anesthesia today remains respiratory complications, particularly those of infectious origin. The care of this population presents a major public health challenge. Studies on the use of curare and especially rocuronium are relatively old and did not study a geriatric population, so in the group aged the average age was 70 years.
Several studies show an increase in the duration of neuromuscular blockade in patients over the age of 70, regardless of any renal failure, with extremes of persistent curarization more than 2 h after a single dose. However, no study to date has investigated the duration of deep-tissue neuromuscular blocking (train of four (TOF) <1) required for performing certain surgical procedures, including laparoscopic surgery.
Several studies show that elderly patients have increased sensitivity to residual curarization.
In this context, a study on the kinetics of the curare and in particular rocuronium is necessary in order to evaluate if the "standard" induction dose of 0.6 mg / kg is adapted to this population or if this dose requires an adjustment to reduce the respiratory risks associated with residual curarization.
General description of the research Objectives To compare the duration of curarization induced by rocuronium (0.6 mg / kg of real weight) between young patients (18-50 years old) and old men (> 80 years old).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients scheduled for surgery with neuromuscular blockade by rocuronium
- •Body mass index between 18.5 and 35
- •Age 18 - 50 years or age > 80 years
Exclusion Criteria
- •Known allergy to rocuronium
- •rapid sequence induction
- •clinical hepatocellular insufficiency
- •renal insufficiency requiring dialysis
- •ASA class > 2 in the group 18-50 years
Arms & Interventions
Young patients
Patients aged 18 - 50 years
Intervention: Pharmacokinetics of rocuronium induced neuromuscular block (Drug)
Geriatric patients
Patients aged ≥ 80 years
Intervention: Pharmacokinetics of rocuronium induced neuromuscular block (Drug)
Outcomes
Primary Outcomes
Total time of neuromuscular block
Time Frame: 4 hours, during surgery
Time from rocuronium injection to total recovery of neuromuscular block
Secondary Outcomes
- Deep neuromuscular block(4 hours, during surgery)
- Recovery time 0.9(4 hours, during surgery)
- Recovery time 1.0(4 hours, during surgery)
- Recovery time 0.9 Tref(4 hours, during surgery)
- Recovery time 1.0 Tref(4 hours, during surgery)