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Clinical Trials/NCT05343689
NCT05343689CompletedNot Applicable

Effect of the Pneumatic Compression of Lower Leg on Post-induction Hypotension in Elderly Patients Undergoing Robot Assisted Laparoscopic Prostatectomy: a Double Blined Randomized Controlled Trial

Asan Medical Center1 site in 1 country100 target enrollmentStarted: May 4, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Incidence of post-induction hypotension

Study Overview

Brief Summary

The purpose of this study is to evaluate the effect of pneumatic compression on post-induction hypotension in elderly patients undergoing robot assisted laparoscopic prostatectomy.

Detailed Description

The purpose of this study is to evaluate the effect of pneumatic compression of lower leg, which is performed during 20 minutes after anesthesia induction period, on post-induction hypotension in elderly patients undergoing robot assisted laparoscopic prostatectomy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 79 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who are scheduled robot assisted laparoscopic prostatectomy under general anesthesia
  • •Elderly patients (between 65 and 79 years old)
  • •American Society of Anesthesiologists physical status ≤3
  • •Patients who are voluntarily agreed to this clinical study

Exclusion Criteria

  • •Uncontrolled hypertension, heart failure (ejection fraction <40%), arrhythmia requiring treatment, unstable coronary artery disease
  • •Patient's denial

Arms & Interventions

Pneumatic compression group

Experimental

When inducing general anesthesia, pneumatic compression is performed.

Intervention: Pneumatic compression (Procedure)

Control group

No Intervention

When inducing general anesthesia, pneumatic compression is not performed.

Outcomes

Primary Outcomes

Incidence of post-induction hypotension

Time Frame: From anesthesia induction to 20 minutes after anesthesia induction

Systolic blood pressure below 90 mmHg

Secondary Outcomes

  • Blood pressure(From anesthesia induction to 20 minutes after anesthesia induction)
  • Heart rate(From anesthesia induction to 20 minutes after anesthesia induction)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Young-Kug Kim, MD

Principal Investigator

Asan Medical Center

Study Sites (1)

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