The Effect of Trendelenburg Position on CCA Blood Flow

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04233177
Collaborator
(none)
20
1
13.4
1.5

Study Details

Study Description

Brief Summary

The investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will include 20 patients undergoing gynecological surgery. The common carotid artery blood flow will be measured using Doppler US during the following conditions; supine position before induction of anesthesia, supine position immediately after induction of anesthesia, supine position with penumoperitoneum, head-down position with or without pneumoperitoneum.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Influence of Anesthesia, Pneumoperitoneum, and Patient Position on Common Carotid Artery Blood Flow During Laparoscopic Gynecology Operation
    Actual Study Start Date :
    Jan 13, 2020
    Actual Primary Completion Date :
    Feb 23, 2021
    Actual Study Completion Date :
    Feb 23, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Change of the common carotid artery blood flow velocity [1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position]

      Common carotid artery blood flow velocity is measured using Doppler US

    Secondary Outcome Measures

    1. Change of the common carotid artery beat volume [1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position]

      Common carotid artery beat volume was calculated from median common carotid artery beat velocity and vessel diameter

    2. Change of the common carotid artery diameter [1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position]

      Common carotid artery diameter is obtained using US

    3. Change of mean arterial blood pressure [1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position]

      Mean arterial pressure is obtained concurrently with common carotid artery blood flow velocity measurements

    4. Change of cardiac output [1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position]

      Cardiac output was obtained using FloTrac(EdwardLifescience, USA)

    5. Change of peak inspiration airway pressure [1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position]

      Peak inspiratory airway pressure is obtained using the ventilator system

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ASA class I,II

    • patients undergoing gynecology surgery under trendelenburg position

    • Age ranges from 20 to 70

    Exclusion Criteria:
    • BMI > 32

    • Pregnancy

    • Patients who did not agree to study

    • Patients with allergies to the drugs used in this study

    • Patients with anatomical variations or lesions in cervical or cranial vascular portion

    • Patients with arrhythmia that may alter patient's cardiac output(e.g. artrial fibrillation)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jin-Tae Kim Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin-Tae Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT04233177
    Other Study ID Numbers:
    • CCA-BF
    First Posted:
    Jan 18, 2020
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 19, 2022