Pneumatic Compression and Post-induction Hypotension

NCT05343689 — Not applicable, Completed, 100 participants, Asan Medical Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT05343689
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	100 (Actual)
Sponsor	Asan Medical Center (Other)
Conditions	Prostate Cancer
Interventions	Pneumatic compression (Procedure)
Dates	start 2022-05-04, primary completion 2022-12-14, completion 2022-12-14, first posted 2022-04-25, last updated 2022-12-30
Locations	1 site in South Korea

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Pneumatic compression group	Experimental	Procedure: Pneumatic compression	When inducing general anesthesia, pneumatic compression is performed.
Control group	No intervention		When inducing general anesthesia, pneumatic compression is not performed.

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.

+Outcome measures

Primary outcomes

Incidence of post-induction hypotension [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]: Blood pressure (systolic, diastolic, and mean)
Heart rate [From anesthesia induction to 20 minutes after anesthesia induction]: Heart rate derived from electrocardiography

+Eligibility

Sex: All, ages: 65 Years to 79 Years

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

+Locations (1)

Facility	City	Country	Status
Asan Medical Center	Seoul	South Korea

+Publications

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. PMID 16115962
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. PMID 23835589
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. PMID 18574271
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. PMID 26543450