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Onset Time of Thiopental Versus Propofol in the Elderly

This study has been completed.
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00965107
First received: August 24, 2009
Last updated: March 8, 2010
Last verified: February 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Onset Time of Thiopental Versus Propofol in the Elderly

Resource links provided by NLM:

Drug Information available for: Propofol
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 24, 2009
Last Updated: March 8, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Danish Medicines Agency

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

ClinicalTrials.gov processed this record on May 23, 2013