- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199522
Clinical Observation of Titration Induction and Convention Induction of Propofol
October 19, 2020 updated by: Lihong Chen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: titration induction of propofol
titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1
|
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
|
NO_INTERVENTION: convention induction of propofol
propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
15minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total dosage of propofol using
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: san q Jin, docter, Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 28, 2014
Primary Completion (ACTUAL)
November 30, 2014
Study Completion (ACTUAL)
November 30, 2014
Study Registration Dates
First Submitted
July 22, 2014
First Submitted That Met QC Criteria
July 22, 2014
First Posted (ESTIMATE)
July 24, 2014
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDMZ-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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