NCT02199522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

July 28, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2014

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

July 22, 2014

Last Update Submit

October 19, 2020

Conditions

Propofol Overdose of Undetermined Intent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • total dosage of propofol using

    15 minutes

Study Arms (2)

titration induction of propofol

EXPERIMENTAL

titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1

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

Interventions

titration induction to propofolPROCEDURE

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

titration induction of propofol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Study Officials

  • san q Jin, docter

    Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Anesthesia ,Sixth Affiliated hospital of Sun Yat-sen University

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 24, 2014

Study Start

July 28, 2014

Primary Completion

November 30, 2014

Study Completion

November 30, 2014

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

CN(1)