Onset Time of Thiopental Versus Propofol in the Elderly

March 8, 2010 updated by: Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
      • Copenhagen, Denmark, 2100
        • Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Thiopental
Thiopental for induction of anaesthesia.
Drug: Thiopental
Thiopental given as a bolus dose of 2,5 mg/kg.
Other Names:
  • Thiomebumalnatrium, thiomebumal
ACTIVE_COMPARATOR: Propofol
Propofol for induction of anaesthesia.
Drug: Propofol
Propofol given as a bolus dose of 1 mg/kg.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

TrygFonden, Denmark

Investigators

  • Principal Investigator: Lars Rasmussen, MD, PHD, Rigshospitalet, Denmark
  • Principal Investigator: Martin K Soerensen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (ESTIMATE)

August 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 8, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1A-AGE/ONSET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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