Onset Time of Thiopental Versus Propofol in the Elderly

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Induction of Anaesthesia; Age

Treatments: Drug: Thiopental; Drug: Propofol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00965107

1A-AGE/ONSET

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups

Thiopental

Experimental group

Description:

Thiopental for induction of anaesthesia.

Treatment:

Drug: Thiopental

Propofol

Active Comparator group

Description:

Propofol for induction of anaesthesia.

Treatment:

Drug: Propofol