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Onset Time of Thiopental Versus Propofol in the Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965107
First Posted: August 25, 2009
Last Update Posted: March 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention Phase
Induction of Anaesthesia Age Drug: Thiopental Drug: Propofol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Onset Time of Thiopental Versus Propofol in the Elderly

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • "Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50. [ Time Frame: 120 seconds ]

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

Estimated Enrollment: 78
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thiopental
Thiopental for induction of anaesthesia.
Drug: Thiopental
Thiopental given as a bolus dose of 2,5 mg/kg.
Other Name: Thiomebumalnatrium, thiomebumal
Active Comparator: Propofol
Propofol for induction of anaesthesia.
Drug: Propofol
Propofol given as a bolus dose of 1 mg/kg.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965107


Locations
Denmark
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
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Lars Rasmussen, MD, PHD Rigshospitalet, Denmark
Principal Investigator: Martin K Soerensen, MD Rigshospitalet, Denmark
  More Information

Responsible Party: Lars Rasmussen, Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
ClinicalTrials.gov Identifier: NCT00965107     History of Changes
Other Study ID Numbers: 1A-AGE/ONSET
First Submitted: August 24, 2009
First Posted: August 25, 2009
Last Update Posted: March 9, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Propofol
Thiopental
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action