NCT05343689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
Last Updated

December 30, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

April 18, 2022

Last Update Submit

December 28, 2022

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-induction hypotension

    Systolic blood pressure below 90 mmHg

    From anesthesia induction to 20 minutes after anesthesia induction

Secondary Outcomes (2)

  • Blood pressure

    From anesthesia induction to 20 minutes after anesthesia induction

  • Heart rate

    From anesthesia induction to 20 minutes after anesthesia induction

Study Arms (2)

Pneumatic compression group

EXPERIMENTAL

When inducing general anesthesia, pneumatic compression is performed.

Procedure: Pneumatic compression

Control group

NO INTERVENTION

When inducing general anesthesia, pneumatic compression is not performed.

Interventions

Pneumatic compressionPROCEDURE

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.

Pneumatic compression group

Eligibility Criteria

Age65 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Uncontrolled hypertension, heart failure (ejection fraction \<40%), arrhythmia requiring treatment, unstable coronary artery disease
  • Patient's denial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (4)

  • 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: 16115962BACKGROUND

  • 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: 23835589BACKGROUND

  • 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: 18574271BACKGROUND

  • 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: 26543450BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

May 4, 2022

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

December 30, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)