Clinical Observation of Titration Induction and Convention Induction of Propofol

Propofol Overdose of Undetermined Intent Clinical Trial

Official title:

Clinical Observation of Titration Induction and Convention Induction of Propofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199522
• Other study ID #: DDMZ-1
• Status: Completed
• Phase: N/A
• Start date: July 28, 2014
• Est. completion date: November 30, 2014

Study information

• Verified date: October 2020
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2014
• Est. primary completion date: November 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with American Society of Anesthesiologists(ASA)?or ? 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.

Related Conditions & MeSH terms

• Drug Overdose
• Propofol Overdose of Undetermined Intent

Intervention

Procedure:
• titration induction to propofol
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

Locations

Country	Name	City	State
China	Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Lihong Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15minutes
Secondary	total dosage of propofol using		15 minutes