Onset Time of Thiopental Versus Propofol in the Elderly
1 other identifier
interventional
78
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2009
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 9, 2010
February 1, 2010
6 months
August 24, 2009
March 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
120 seconds
Secondary Outcomes (4)
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
Study Arms (2)
Thiopental
EXPERIMENTALThiopental for induction of anaesthesia.
Propofol
ACTIVE COMPARATORPropofol for induction of anaesthesia.
Interventions
Thiopental given as a bolus dose of 2,5 mg/kg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
- "Body Mass Index" (BMI) \<18 and \> 35.
- NYHA-class \> 2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- TrygFonden, Denmarkcollaborator
Study Sites (2)
Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100, Denmark
Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Rasmussen, MD, PHD
Rigshospitalet, Denmark
- PRINCIPAL INVESTIGATOR
Martin K Soerensen, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 25, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
March 9, 2010
Record last verified: 2010-02