Use of Perfusion Index Change as a Predictor of Hypotension During Propofol Sedation in Adult Patients Undergoing Hip Surgery Under Spinal Anesthesia: A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center, Sungkyunkwan University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Propofol sedation after SA; Participants who undergo propofol sedation after spinal anesthesia	Other: Observation; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-minute perfusion index change difference	difference of perfusion index change 5 minutes after induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia (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 difference	difference of perfusion index change 10 minutes after induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia (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 difference	difference of baseline perfusion index between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia	After sedation until start of surgery (an average of 20 minutes)
5-minute perfusion index difference	difference of perfusion index after 5 minutes of induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia	After sedation until start of surgery (an average of 20 minutes)
10-minute perfusion index difference	difference of perfusion index after 10 minutes of induction between participants who do or do not develop hypotension during propofol sedation after spinal anesthesia	After sedation until start of surgery (an average of 20 minutes)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2018
• Primary Completion (ACTUAL): January 30, 2019
• Study Completion (ACTUAL): February 15, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (ACTUAL): June 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2018-03-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No