Cardiac Performance During Steep Trendelenburg Position in Patients Undergoing Robotic Surgery Surgery.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarlstad Central Hospital
About this trial
The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent.
The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.
In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning
During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Age <18;
Dementia,
Not able to give written consent -
Trial population
Consecutive Patients scheduled for robotic surgery in Tendelenburg positioning.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Esophageal Doppler
DeviceEsophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Patients with Preoperative EF: 50% or higher1 intervention
Group B: Patients with Preoperative EF: 45% or lower1 intervention
Group C: Patients without intrathecal bupivacain and morphine.1 intervention
Trial outcomes
Primary outcomes
1
Change of Stroke Volume during Trendelenburg position and pneumoperitoneum.
Esophageal Doppler Monitoring
Time frame
During 15 minutes after reaching position.Secondary outcomes
1
% Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected
Esophageal Doppler Monitoring
Time frame
During 15 minutes after reaching position2
% change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum.
INVivoOpticalSpectroscopy
Time frame
During 15 min after reaching position.Sponsors and contacts
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Source ClinicalTrials.gov