Onset Time of Thiopental Versus Propofol in the Elderly

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00965107

Enrollment

Registered

2009-08-25

Start date

2009-09-30

Completion date

2010-03-31

Last updated

2010-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Anaesthesia, Age

Brief 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.

Interventions

DRUGThiopental

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

DRUGPropofol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Onset-time defined as the time from started induction bolus to: - Time to BIS-value <50.	120 seconds

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026