Clinical trial NCT03882697: Ability of Cardio Q for Prediction of Hypotension
Official title: Ability of Cardio Q for Prediction of Hypotension After Postural Change in Robot-Assisted Laparoscopic Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Robotic surgery
Position
Cardio Q
hypotension
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 125
Sex: MALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA 1-3 Patient undergoing robot-assisted laparoscopic radical prostatectomy

Brief summary: Evaluation the ability of each indicator of Cardio Q in predicting hypotension after position changes in robot-assisted laparoscopic radical prostatectomy

Detailed description: Hypotension is common in patients who undergo general anesthesia. Hypotension may cause hypoperfusion in the organs of the body, resulting in ischemia and increased mortality within one year. Hypotension may occur at any time during general anesthesia but may also occur with changes in posture. In robot-assisted laparoscopic radical prostatectomy, hypotension often occurs when posture is changed from a Trendelenburg position to a supine position. However there is no data regarding which hemodynamic parameters can predict hypotension induced by position change.

Excessive administration of the fluid in steep Trendelenburg position may lead to fluid overload and lead to complications such as pulmonary edema. Thus, the predictors are should be identified to manage patients without fluid overload. Therefore, the aim of this study is to investigate the parameters of Cardio Q which are useful for predicting hypotension after position change.

Eligibility criteria: Inclusion Criteria:

Patients undergoing robot-assisted laparoscopic radical prostatectomy ASA 1-3

Exclusion Criteria:

Patients that

* Unstable angina, left ventricular ejection fraction \<40%
* Severe vascular disease
* Insertion type : pacemaker / defibrillator
* Autonomic nervous system diseases
* When esophageal varices are present
* If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

Primary outcomes:
measure: Mean arterial pressure
timeFrame: Before position change, After position change (1, 3, 5, 7, and 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: So Yeon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim NY, Kim KJ, Kim TL, Shin HJ, Oh C, Lee MH, Min JY, Kim SY. Prediction of hypotension after postural change in robot-assisted laparoscopic prostatectomy using esophageal Doppler monitoring: a prospective observational trial. Sci Rep. 2021 Jul 16;11(1):14589. doi: 10.1038/s41598-021-93990-3.