Prostate CancerNCT05343689
Pneumatic Compression and Post-induction Hypotension
A study testing Pneumatic compression in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pneumatic compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 May 2022to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled hypertension, heart failure (ejection fraction <40%), arrhythmia requiring treatment, unstable coronary artery disease
- Patient's denial
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Pneumatic compression
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic compressionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic compression group | Experimental | When inducing general anesthesia, pneumatic compression is performed. Receives: Procedure: Pneumatic compression |
| Control group | No intervention | When inducing general anesthesia, pneumatic compression is not performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-induction hypotension
Systolic blood pressure below 90 mmHg
Measured: From anesthesia induction to 20 minutes after anesthesia induction
Secondary outcomes (2)
Blood pressure
Blood pressure (systolic, diastolic, and mean)
Measured: From anesthesia induction to 20 minutes after anesthesia induction
Heart rate
Heart rate derived from electrocardiography
Measured: From anesthesia induction to 20 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start4 May 2022
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343689
- Sponsor's protocol ID
- 2022-0495
- Status last verified
- Dec 2022
- First submitted
- 18 Apr 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16115962Walsh 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.
PubMed 23835589Geerts 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.
PubMed 18574271Golparvar 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.
PubMed 26543450
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05343689
- Acronym / sponsor ID
- 2022-0495
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic compression group | Experimental | Procedure: Pneumatic compressionWhen inducing general anesthesia, pneumatic compression is performed. |
| Control group | No intervention | –When inducing general anesthesia, pneumatic compression is not performed. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Uncontrolled hypertension, heart failure (ejection fraction <40%), arrhythmia requiring treatment, unstable coronary artery disease
- Patient's denial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumatic compressionPneumatic compression with preset pressure and cyclic manner is applied from immediately after anesthesia induction to 20 minutes after anesthesia induction in the both legs. | Procedure or surgery | Pneumatic compression group |
Primary outcome
Incidence of post-induction hypotension
Time frame: From anesthesia induction to 20 minutes after anesthesia induction
Systolic blood pressure below 90 mmHg
2 secondary outcomes
Blood pressure
Time frame: From anesthesia induction to 20 minutes after anesthesia induction
Heart rate
Time frame: From anesthesia induction to 20 minutes after anesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Background: PubMed 16115962Reich 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.
- Background: PubMed 23835589Walsh 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.
- Background: PubMed 18574271Geerts 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.
- Background: PubMed 26543450Golparvar 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.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic compression in people with Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-induction hypotension (time frame: From anesthesia induction to 20 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343689, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.