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NCT04233177 Clinical Trial

The Effect of Trendelenburg Position on CCA Blood Flow

Perioperative/Postoperative Complications Clinical Trial

Official title:
Influence of Anesthesia, Pneumoperitoneum, and Patient Position on Common Carotid Artery Blood Flow During Laparoscopic Gynecology Operation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04233177
Other study ID # CCA-BF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 13, 2020
Est. completion date February 23, 2021

Study information
Verified date January 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 23, 2021
Est. primary completion date February 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Jin-Tae Kim Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of the common carotid artery blood flow velocity Common carotid artery blood flow velocity is measured using Doppler US 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
Secondary Change of the common carotid artery beat volume Common carotid artery beat volume was calculated from median common carotid artery beat velocity and vessel 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
Secondary Change of the common carotid artery diameter Common carotid artery diameter is obtained using US 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
Secondary Change of mean arterial blood pressure Mean arterial pressure is obtained concurrently with common carotid artery blood flow velocity measurements 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
Secondary Change of cardiac output Cardiac output was obtained using FloTrac(EdwardLifescience, USA) 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
Secondary Change of peak inspiration airway pressure Peak inspiratory airway pressure is obtained using the ventilator system 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
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