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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03556969
Enrollment
39
Registered
2018-06-14
Start date
2018-05-21
Completion date
2019-02-15
Last updated
2022-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

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.

Interventions

OTHERObservation

no intervention

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
10-minute perfusion indexAfter sedation until start of surgery (an average of 20 minutes)ability of perfusion index 10 minutes after induction in predicting propofol sedation-induced hypotension
5-minute perfusion index changeAfter 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 changeAfter 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 indexAfter sedation until start of surgery (an average of 20 minutes)ability of baseline perfusion index in predicting propofol sedation-induced hypotension
5-minute perfusion indexAfter sedation until start of surgery (an average of 20 minutes)ability of perfusion index 5 minutes after induction in predicting propofol sedation-induced hypotension

Secondary

MeasureTime frameDescription
5-minute perfusion index change differenceAfter 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 differenceAfter 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 differenceAfter 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
5-minute perfusion index differenceAfter 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 differenceAfter 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026