Back to resultsClinical Observation of Titration Induction and Convention Induction of Propofol
Primary Purpose
Propofol Overdose of Undetermined Intent
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
titration induction to propofol
Sponsored by
About this trial
This is an interventional treatment trial for Propofol Overdose of Undetermined Intent
Eligibility Criteria
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.
Sites / Locations
- Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
titration induction of propofol
convention induction of propofol
Arm Description
titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1
propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
total dosage of propofol using
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02199522
Brief Title
Clinical Observation of Titration Induction and Convention Induction of Propofol
Official Title
Clinical Observation of Titration Induction and Convention Induction of Propofol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 28, 2014 (Actual)
Primary Completion Date
November 30, 2014 (Actual)
Study Completion Date
November 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lihong Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Propofol Overdose of Undetermined Intent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
titration induction of propofol
Arm Type
Experimental
Arm Description
titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1
Arm Title
convention induction of propofol
Arm Type
No Intervention
Arm Description
propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1
Intervention Type
Procedure
Intervention Name(s)
titration induction to propofol
Intervention Description
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
Primary Outcome Measure Information:
Title
systolic pressure diastolic pressure mean blood pressure
Description
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
Time Frame
15minutes
Secondary Outcome Measure Information:
Title
total dosage of propofol using
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
san q Jin, docter
Organizational Affiliation
Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Observation of Titration Induction and Convention Induction of Propofol
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