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CompletedNCT00965107Updated Mar 9, 2010

Onset Time of Thiopental Versus Propofol in the Elderly

A Phase 4 interventional study of Thiopental and Propofol in Induction of Anaesthesia and Age, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 2 sites in Denmark. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2010-03-09.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Induction of Anaesthesia
  • Age
03

In context

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 34 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
  • "Body Mass Index" (BMI) \<18 and > 35.
  • NYHA-class > 2.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Thiopental

    Thiopental for induction of anaesthesia.

    Drug: Thiopental

  • Active comparator
    Propofol

    Propofol for induction of anaesthesia.

    Drug: Propofol

Interventions

  • DrugThiopental

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

    Also known as: Thiomebumalnatrium, thiomebumal

  • DrugPropofol

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

06

What researchers measure

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

07

Study locations

2 sites
  • 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
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Mar 2010 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2009
First posted
Aug 25, 2009
Start
Sep 2009
Primary completionActual
Mar 2010
CompletionActual
Mar 2010
Last update
Mar 9, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00965107
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Collaborators
TrygFonden, Denmark
First posted
Aug 25, 2009
Start date
Sep 2009
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Mar 9, 2010

Study contacts

Lars Rasmussen, MD, PHD
principal investigator · Copenhagen University Hospital, Rigshospitalet
Martin K Soerensen, MD
principal investigator · Copenhagen University Hospital, Rigshospitalet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Thiopental

Other studies from this sponsor

Copenhagen University Hospital, Rigshospitalet

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