Back to resultsPneumatic Compression and Post-induction Hypotension
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pneumatic compression
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pneumatic compression group
Control group
Arm Description
When inducing general anesthesia, pneumatic compression is performed.
When inducing general anesthesia, pneumatic compression is not performed.
Outcomes
Primary Outcome Measures
Incidence of post-induction hypotension
Systolic blood pressure below 90 mmHg
Secondary Outcome Measures
Blood pressure
Blood pressure (systolic, diastolic, and mean)
Heart rate
Heart rate derived from electrocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05343689
Brief Title
Pneumatic Compression and Post-induction Hypotension
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pneumatic compression group
Arm Type
Experimental
Arm Description
When inducing general anesthesia, pneumatic compression is performed.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
When inducing general anesthesia, pneumatic compression is not performed.
Intervention Type
Procedure
Intervention Name(s)
Pneumatic compression
Intervention Description
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 Outcome Measure Information:
Title
Incidence of post-induction hypotension
Description
Systolic blood pressure below 90 mmHg
Time Frame
From anesthesia induction to 20 minutes after anesthesia induction
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure (systolic, diastolic, and mean)
Time Frame
From anesthesia induction to 20 minutes after anesthesia induction
Title
Heart rate
Description
Heart rate derived from electrocardiography
Time Frame
From anesthesia induction to 20 minutes after anesthesia induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16115962
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.
Results Reference
background
PubMed Identifier
23835589
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.
Results Reference
background
PubMed Identifier
18574271
Citation
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.
Results Reference
background
PubMed Identifier
26543450
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.
Results Reference
background
Learn more about this trial
Pneumatic Compression and Post-induction Hypotension
We'll reach out to this number within 24 hrs