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NCT Number: NCT03556969

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Spinal Anesthetics Causing Adverse Effects in Therapeutic Use Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

no intervention

Primary outcomes

  1. 5-minute perfusion index change

    Time frame: 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)

  2. 10-minute perfusion index change

    Time frame: 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)

  3. baseline perfusion index

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

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

  4. 5-minute perfusion index

    Time frame: 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

  5. 10-minute perfusion index

    Time frame: 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 outcomes

  1. 5-minute perfusion index change difference

    Time frame: 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)

  2. 10-minute perfusion index change difference

    Time frame: 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)

  3. baseline perfusion index difference

    Time frame: 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

  4. 5-minute perfusion index difference

    Time frame: 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

  5. 10-minute perfusion index difference

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2018
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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