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Completed

NCT Number: NCT05343689

Pneumatic Compression and Post-induction Hypotension

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

65 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pneumatic compression

Procedure

Pneumatic compression with preset pressure and cyclic manner is applied from immediately after anesthesia induction to 20 minutes after anesthesia induction in the both legs.

Primary outcomes

  1. Incidence of post-induction hypotension

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

    Systolic blood pressure below 90 mmHg

Secondary outcomes

  1. Blood pressure

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

    Blood pressure (systolic, diastolic, and mean)

  2. Heart rate

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

    Heart rate derived from electrocardiography

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2022
Registry last updated
Dec 30, 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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