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Completed

NCT Number: NCT00965107

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.

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Key information

Conditions

Induction of Anaesthesia Age

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thiopental

Drug

Thiopental given as a bolus dose of 2,5 mg/kg.

Other names: Thiomebumalnatrium, thiomebumal

Propofol

Drug

Propofol given as a bolus dose of 1 mg/kg.

Primary outcomes

  1. "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.

    Time frame: 120 seconds

Secondary outcomes

  1. Hemodynamical effect (bloodpressure/pulse) every 60 seconds.

    Time frame: 120 seconds

  2. "Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.

    Time frame: 120 seconds

  3. "Onset-time" defined as the time from started induction bolus to: - Time to eye closure.

    Time frame: 120 seconds

  4. "Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.

    Time frame: 120 seconds

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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