Onset Time of Thiopental Versus Propofol in the Elderly

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: Thiopental
    • Thiopental given as a bolus dose of 2,5 mg/kg.
  • Drug: Propofol
    • Propofol given as a bolus dose of 1 mg/kg.

Arms, Groups and Cohorts

  • Experimental: Thiopental
    • Thiopental for induction of anaesthesia.
  • Active Comparator: Propofol
    • Propofol for induction of anaesthesia.

Clinical Trial Outcome Measures

Primary Measures

  • “Onset-time” defined as the time from started induction bolus to: – Time to BIS-value <50.
    • Time Frame: 120 seconds

Secondary Measures

  • Hemodynamical effect (bloodpressure/pulse) every 60 seconds.
    • Time Frame: 120 seconds
  • “Onset-time” defined as the time from started induction bolus to: – Time to loss of grip.
    • Time Frame: 120 seconds
  • “Onset-time” defined as the time from started induction bolus to: – Time to eye closure.
    • Time Frame: 120 seconds
  • “Onset-time” defined as the time from started induction bolus to: – Time to ciliary reflex cessation.
    • Time Frame: 120 seconds

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Collaborator
    • TrygFonden, Denmark
  • Provider of Information About this Clinical Study
    • Lars Rasmussen, Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
  • Overall Official(s)
    • Lars Rasmussen, MD, PHD, Principal Investigator, Rigshospitalet, Denmark
    • Martin K Soerensen, MD, Principal Investigator, Rigshospitalet, Denmark

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