Propofol Overdose of Undetermined IntentNCT02199522
Clinical Observation of Titration Induction and Convention Induction of Propofol
A study testing titration induction to propofol in people with Propofol Overdose of Undetermined Intent, run by Lihong Chen at 1 site in China.
Trial summary
As we know propofol is popular use in the anesthesia induction with kilogram and it always cause hypotension. So we compare haemodynamic changes and drug consumption between propofol titrated administration and traditional administration for anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Propofol Overdose of Undetermined Intent
- What is being tested?
- titration induction to propofol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2014to 30 Nov 2014
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia.
Who cannot join
- Hypertension, Severe heart,pulmonary,brain，liver and renal dysfunction; excess obesity , predicted difficult intubation,hearing obstacles;. Allergic to propofol or its fat emulsion;addictive to sedative and other drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
As we know propofol is popular use in the anesthesia induction with kilogram and it always cause hypotension. So we compare haemodynamic changes and drug consumption between propofol titrated administration and traditional administration for anesthesia induction.
Read the detailed description
GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min, GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to 1, then changed to a maintenance dose
- Conditions
- Propofol Overdose of Undetermined Intent
- Being tested
- titration induction to propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titration induction to propofolProcedure or surgery
propofol intravenously by Fresenius pump at the speed of 1 mg•kg-1•min-1, and OAA/S scale of the patients was titrated to 1
| Study group | Role | What they receive |
|---|---|---|
| titration induction of propofol | Experimental | titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1 Receives: Procedure: titration induction to propofol |
| convention induction of propofol | No intervention | propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic pressure diastolic pressure mean blood pressure
before propofol dosage ,1 min after the propofol dosage, 3 min , 5 min
, endotracheal intubation done immediately,1 min,3 min,5 min,7 min,9 min after endotracheal intubation
Measured: 15minutes
Secondary outcomes (1)
total dosage of propofol using
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study start28 Jul 2014
- Primary completion30 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Overdose of Undetermined IntentStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lihong Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lihong Chen, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- san q Jin, docter, Principal investigator, Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199522
- Sponsor's protocol ID
- DDMZ-1
- Status last verified
- Oct 2020
- First submitted
- 22 Jul 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Titration Induction and Convention Induction of Propofol
- ClinicalTrials.gov ID
- NCT02199522
- Acronym / sponsor ID
- DDMZ-1
- Conditions
- Propofol Overdose of Undetermined Intent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Lihong ChenUniversity, hospital or other
- Study start
- 28 Jul 2014 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 24 Jul 2014 (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.
As we know propofol is popular use in the anesthesia induction with kilogram and it always cause hypotension. So we compare haemodynamic changes and drug consumption between propofol titrated administration and traditional administration for anesthesia induction.
Detailed description
GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min, GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to 1, then changed to a maintenance dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| titration induction of propofol | Experimental | Procedure: titration induction to propofoltitration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1 |
| convention induction of propofol | No intervention | –propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia.
Key exclusion criteria (1 listed)
- Hypertension, Severe heart,pulmonary,brain，liver and renal dysfunction; excess obesity , predicted difficult intubation,hearing obstacles;. Allergic to propofol or its fat emulsion;addictive to sedative and other drugs.
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 |
|---|---|---|
| titration induction to propofolpropofol intravenously by Fresenius pump at the speed of 1 mg•kg-1•min-1, and OAA/S scale of the patients was titrated to 1 | Procedure or surgery | titration induction of propofol |
Primary outcome
systolic pressure diastolic pressure mean blood pressure
Time frame: 15minutes
before propofol dosage ,1 min after the propofol dosage, 3 min , 5 min , endotracheal intubation done immediately,1 min,3 min,5 min,7 min,9 min after endotracheal intubation
1 secondary outcome
total dosage of propofol using
Time frame: 15 minutes
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 22 Oct 2020.
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.
san q Jin, docter principal investigator
Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing titration induction to propofol in people with Propofol Overdose of Undetermined Intent, run by Lihong Chen at 1 site in China.
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 1 inclusion and 1 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
systolic pressure diastolic pressure mean blood pressure (time frame: 15minutes). 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 22 Oct 2020.