Onset Time of Thiopental Versus Propofol in the Elderly

Phase 4

Completed

• Conditions: Induction of Anaesthesia; Age
• Interventions: Drug: Thiopental; Drug: Propofol

• Registration Number: NCT00965107
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2009-09
• Status Verified: 2010-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-08
• Last Update Posted: 2010-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thiopental	Thiopental	Thiopental for induction of anaesthesia.
Propofol	Propofol	Propofol for induction of anaesthesia.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

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

Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark