NCT03556969

Brief Summary

This observational study is to evaluate Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

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

Study Start

First participant enrolled

May 21, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

June 4, 2018

Last Update Submit

August 21, 2022

Conditions

HypotensionSpinal Anesthetics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (5)

  • 5-minute perfusion index change

    ability of perfusion index change 5 minutes after induction in predicting propofol sedation-induced hypotension (perfusion index change is calculated as the percent change from baseline values)

    After sedation until start of surgery (an average of 20 minutes)

  • 10-minute perfusion index change

    ability of perfusion index change 10 minutes after induction in predicting propofol sedation-induced hypotension (perfusion index change is calculated as the percent change from baseline values)

    After sedation until start of surgery (an average of 20 minutes)

  • baseline perfusion index

    ability of baseline perfusion index in predicting propofol sedation-induced hypotension

    After sedation until start of surgery (an average of 20 minutes)

  • 5-minute perfusion index

    ability of perfusion index 5 minutes after induction in predicting propofol sedation-induced hypotension

    After sedation until start of surgery (an average of 20 minutes)

  • 10-minute perfusion index

    ability of perfusion index 10 minutes after induction in predicting propofol sedation-induced hypotension

    After sedation until start of surgery (an average of 20 minutes)

Secondary Outcomes (5)

  • 5-minute perfusion index change difference

    After sedation until start of surgery (an average of 20 minutes)

  • 10-minute perfusion index change difference

    After sedation until start of surgery (an average of 20 minutes)

  • baseline perfusion index difference

    After sedation until start of surgery (an average of 20 minutes)

  • 5-minute perfusion index difference

    After sedation until start of surgery (an average of 20 minutes)

  • 10-minute perfusion index difference

    After sedation until start of surgery (an average of 20 minutes)

Study Arms (1)

Propofol sedation after SA

Participants who undergo propofol sedation after spinal anesthesia

Other: Observation

Interventions

ObservationOTHER

no intervention

Propofol sedation after SA

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from both genders, ranging from young to very old patients.

You may qualify if:

  • Adult patients having hip surgery under spinal anesthesia and propofol sedation

You may not qualify if:

  • ASA class IV or above
  • pregnancy
  • inability to measure noninvasive blood pressure on the arm
  • preexisting hemodynamic instability
  • known peripheral artery occlusive disease
  • known autonomic nerve dysfunction
  • uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Hypotension

Interventions

Observation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 14, 2018

Study Start

May 21, 2018

Primary Completion

January 30, 2019

Study Completion

February 15, 2019

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations

KR(1)