Pneumatic Compression and Post-induction Hypotension

Prostate Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343689
• Other study ID #: 2022-0495
• Status: Completed
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: December 2022
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Prostate Cancer

Intervention

Procedure:
• Pneumatic compression
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656. — View Citation

Golparvar M, Saghaei M, Saadati MA, Farsaei S. Effect of ondansetron on prevention of post-induction hypotension in elderly patients undergoing general anesthesia: A randomized, double-blind placebo-controlled clinical trial. Saudi J Anaesth. 2015 Oct-Dec;9(4):365-9. doi: 10.4103/1658-354X.159455. — View Citation

Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91. — View Citation

Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-induction hypotension	Systolic blood pressure below 90 mmHg	From anesthesia induction to 20 minutes after anesthesia induction
Secondary	Blood pressure	Blood pressure (systolic, diastolic, and mean)	From anesthesia induction to 20 minutes after anesthesia induction
Secondary	Heart rate	Heart rate derived from electrocardiography	From anesthesia induction to 20 minutes after anesthesia induction