Induction of AnaesthesiaPhase 4NCT00965107
Onset Time of Thiopental Versus Propofol in the Elderly
A Phase 4 study testing Thiopental and Propofol in people with Induction of Anaesthesia and Age, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Induction of Anaesthesia, Age
- What is being tested?
- Thiopental and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
- "Body Mass Index" (BMI) <18 and > 35.
- NYHA-class > 2.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Anesthesia, Center of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Department of Anesthesia, Juliane Marie Center, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
About this study
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.
- Conditions
- Induction of Anaesthesia, Age
- Being tested
- Thiopental, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiopentalDrug
Also called Thiomebumalnatrium, thiomebumal
Thiopental given as a bolus dose of 2,5 mg/kg.
PropofolDrug
Propofol given as a bolus dose of 1 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Thiopental | Experimental | Thiopental for induction of anaesthesia. Receives: Drug: Thiopental |
| Propofol | Active comparator | Propofol for induction of anaesthesia. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
Measured: 120 seconds
Secondary outcomes (4)
Hemodynamical effect (bloodpressure/pulse) every 60 seconds.
Measured: 120 seconds
"Onset-time" defined as the time from started induction bolus to: - Time to loss of grip.
Measured: 120 seconds
"Onset-time" defined as the time from started induction bolus to: - Time to eye closure.
Measured: 120 seconds
"Onset-time" defined as the time from started induction bolus to: - Time to ciliary reflex cessation.
Measured: 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Investigators
- Lars Rasmussen, MD, PHD, Principal investigator, Copenhagen University Hospital, RigshospitaletMartin K Soerensen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965107
- Sponsor's protocol ID
- 1A-AGE/ONSET
- Status last verified
- Feb 2010
- First submitted
- 24 Aug 2009
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onset Time of Thiopental Versus Propofol in the Elderly
- ClinicalTrials.gov ID
- NCT00965107
- Acronym / sponsor ID
- 1A-AGE/ONSET
- Conditions
- Induction of Anaesthesia, Age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiopental | Experimental | Drug: ThiopentalThiopental for induction of anaesthesia. |
| Propofol | Active comparator | Drug: PropofolPropofol for induction of anaesthesia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
- "Body Mass Index" (BMI) <18 and > 35.
- NYHA-class > 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiopentalAlso: Thiomebumalnatrium, thiomebumalThiopental given as a bolus dose of 2,5 mg/kg. | Drug | Thiopental |
| PropofolPropofol given as a bolus dose of 1 mg/kg. | Drug | Propofol |
Primary outcome
"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50.
Time frame: 120 seconds
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Rasmussen, MD, PHD principal investigator
Copenhagen University Hospital, Rigshospitalet
Martin K Soerensen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thiopental and Propofol in people with Induction of Anaesthesia and Age, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Onset-time" defined as the time from started induction bolus to: - Time to BIS-value <50. (time frame: 120 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2010.