Onset Time of Thiopental Versus Propofol in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Induction of Anaesthesia Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Thiopental

Thiopental for induction of anaesthesia.

Group Type EXPERIMENTAL

Thiopental

Intervention Type DRUG

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

Propofol

Propofol for induction of anaesthesia.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Thiopental

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

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Thiomebumalnatrium, thiomebumal

Eligibility Criteria

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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.