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

Completed

• Conditions: Hypotension; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
• Interventions: Other: Observation

• Registration Number: NCT03556969
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-14
• Primary Completion: 2019-01-30
• Study Completion: 2019-02-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-21
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol sedation after SA	Observation	Participants who undergo propofol sedation after spinal anesthesia

Primary Outcome Measures

Name	Time	Method
5-minute perfusion index change	After sedation until start of surgery (an average of 20 minutes)	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)
10-minute perfusion index change	After sedation until start of surgery (an average of 20 minutes)	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)
baseline perfusion index	After sedation until start of surgery (an average of 20 minutes)	ability of baseline perfusion index in predicting propofol sedation-induced hypotension
5-minute perfusion index	After sedation until start of surgery (an average of 20 minutes)	ability of perfusion index 5 minutes after induction in predicting propofol sedation-induced hypotension
10-minute perfusion index	After sedation until start of surgery (an average of 20 minutes)	ability of perfusion index 10 minutes after induction in predicting propofol sedation-induced hypotension

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine; 🇰🇷 Seoul, Korea, Republic of