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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556969
• Other study ID #: 2018-03-052
• Status: Completed
• Start date: May 21, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: August 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 15, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Intervention

Other:
• Observation
no intervention

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University, School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)