Onset Time of Thiopental Versus Propofol in the Elderly
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Induction of Anaesthesia; Age
Intervention: Thiopental (Drug); Propofol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Rigshospitalet, Denmark Official(s) and/or principal investigator(s): Lars Rasmussen, MD, PHD, Principal Investigator, Affiliation: Rigshospitalet, Denmark Martin K Soerensen, MD, Principal Investigator, Affiliation: Rigshospitalet, Denmark
Summary
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.
Clinical Details
Official title: Onset Time of Thiopental Versus Propofol in the Elderly
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
Secondary outcome: Hemodynamical effect (bloodpressure/pulse) every 60 seconds."Onset-time" defined as the time from started induction bolus to: - Time to loss of grip. "Onset-time" defined as the time from started induction bolus to: - Time to eye closure. "Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Copenhagen 2100, Denmark
Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet, Copenhagen 2100, Denmark
Additional Information
Starting date: September 2009
Last updated: March 8, 2010
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