Age Clinical Trial
Official title:
Onset Time of Thiopental Versus Propofol in the Elderly
This study is aimed at increasing the safety of the use of anaesthesia in an elderly population (> 60 years). Patients with decreased physiological reserve, including all elderly patients, have an increased risk of getting an erroneous induction bolus. This project will investigate how fast elderly patients (> 60 years) fall asleep during bolus induction of anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be evaluated.
Status | Completed |
Enrollment | 78 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - Elective surgical patients above 60 years of age, with an indication of general anaesthesia during surgery. - Informed consent. - The patient must be legally competent. - The patient must be able to read and understand Danish. Exclusion Criteria: - Known allergic reactions to thiopental, propofol, lidocaine or alfentanil - "Body Mass Index" (BMI) <18 and > 35. - NYHA-class > 2. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet | Copenhagen | |
Denmark | Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | TrygFonden, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50. | 120 seconds | Yes | |
Secondary | Hemodynamical effect (bloodpressure/pulse) every 60 seconds. | 120 seconds | Yes | |
Secondary | "Onset-time" defined as the time from started induction bolus to: - Time to loss of grip. | 120 seconds | Yes | |
Secondary | "Onset-time" defined as the time from started induction bolus to: - Time to eye closure. | 120 seconds | Yes | |
Secondary | "Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation. | 120 seconds | Yes |
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