Cardiac Performance During Steep Trendelenburg Position in Patients Undergoing Robotic Surgery Surgery.

NCT06336746 | Recruiting

• 1 other identifier: RHenningsson
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure, Systolic; Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• Change of Stroke Volume during Trendelenburg position and pneumoperitoneum.

  Esophageal Doppler Monitoring

  During 15 minutes after reaching position.

Secondary Outcomes (2)

• % Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected

  During 15 minutes after reaching position

• % change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum.

  During 15 min after reaching position.

Study Arms (3)

Patients with Preoperative EF: 50% or higher

Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured.

Device: Esophageal Doppler

Patients with Preoperative EF: 45% or lower

Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured.

Device: Esophageal Doppler

Patients without intrathecal bupivacain and morphine.

The routine is that all patient receive an intrathecal injection of morphine and bupivacain before start of anesthesia. Patients who have contraindications for spinal anesthesia will be collected in this group.

Device: Esophageal Doppler

Interventions

Esophageal Doppler DEVICE

Esophageal Doppler: measuring cardiac performance. INVOS: measuring regional saturation of the brain.

Also known as: InVivo Optical Spectroscopy INVOS

Patients with Preoperative EF: 45% or lower; Patients with Preoperative EF: 50% or higher; Patients without intrathecal bupivacain and morphine.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive Patients scheduled for robotic surgery in Tendelenburg positioning.

You may qualify if:

• \. Consecutive Patients Scheduled for Robotic Surgery with Trendelenburg positioning.

You may not qualify if:

• Age \<18;
• Dementia,
• Not able to give written consent -

Sponsors & Collaborators

• Karlstad Central Hospital: lead

Study Sites (1)

Dpt of Anesthesiology&Intensive Care; Central Hospital of Karlstad

Karlstad, Värmland County, 65230, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Ragnar N Henningsson, Associate Professor

CONTACT

+46108317434; ragnar.henningsson@regionvarmland.se

Ann-Sofie Lorentzon, ND

CONTACT

Ann-Sofie.Lorentzon@regionvarmland.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: March 29, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

SE (1)