Does Positioning Effects on Early Postoperative Cognitive Dysfunction in Laparoscopic Oncological Surgery

NCT04714346 | Completed

• 1 other identifier: 2019-08/384
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery is an alternative to open surgical techniques for reasons such as less blood loss,less need for transfusion, shorter discharge time. In laparoscopic cases, various positions are given to patients, especially trendelenburg, in order to remove organs and see the area of the operation more easily. The Trendelenburg position causes cerebrovascular changes.Several studies have reported an increase in intracranial pressure (ICP)at the Trendelenburg position. There are also studies that show brain tissue oxygen saturation (SctO2) decreases in this position. Research has reported that cerebral perfusion pressure decreases if the position lasts longer.When pneumoperitonium is administered during laparoscopic surgery, cerebral blood flow may increase as a result of the increase in PaCO2.Brain tissue oxygen saturation depends on blood flow.There is also an inverse ratio between end tidal CO2. To prevent deterioration of cerebral function, methods are needed that determine the onset of desaturation and make early intervention possible. The method,known as near-infrared spectroscopy (NIRS), offers a fixed non-invasive and safe method of determining cerebral desaturation.In addition, NIRS has the potential to improve patient outcomes, reduce postoperative complications and duration of post-anesthesia care.Changes in NIRS measurement values associated with position, especially today, are seen in cerebral perfusion in patients undergoing major surgery, oxygenation and postop have been associated with cognitive dysfunction in the process.Postoperative cognitive dysfunction is associated with increased mortality and therefore it is very important to identify factors that increase risk in order to take appropriate protective measures.Intracerebral ischemia and desaturation may be responsible for the development of POCD. In this study, we aimed to observe NIRS changes due to Trendelenburg position and pneumoperitonium in patients undergoing laparoscopic major abdominal oncological surgery and to examine the effect of POCD on early stage.

Conditions

Ischemic Attack, Transient

Keywords

POCD; Trendelenburg position; pneumoperitonium; NIRS; MMSE

Outcome Measures

Primary Outcomes (1)

• MMSE changings in POCD

  Lowest MMSE score is 0;highest is 30. 24 is the limit of mild cognitive decline. In MMSE, to evaluate cognitive changings 4 point of decline is meaningful. Primarily, In our study, First patients with preoperative MMSE score(M0) 24/30 points and above will be re-evaluated on postoperative seventh day(M1) and those with a decrease of 4 points and greater than M0 score in M1 score will be evaluated as POCD.

  each patient in seven days

Secondary Outcomes (1)

• NIRS measurement correlation

  each patient in seven days

Interventions

no interventions OTHER

there is no intervention

Eligibility Criteria

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

Study Population

Patients who do not meet the exclusion criteria will undergo laparoscopic major abdominal oncological surgery over the age of 18.

You may qualify if:

• years and above,
• points and above on MMSE test,
• Laparoscopic major abdominal oncological surgery planned patients who will receive general anesthesia

You may not qualify if:

• People with a history of cerebral ischemia or hemorrhage,
• Those with a history of neurodegenerative disease,
• Those with diagnosed carotid stenosis,
• Those with a score of 23 and below on the MMSE test,
• Those with a history of Carotid Endarterectomy,
• Patients who have undergone aneurysm surgery,
• Those who are addicted to alcohol,
• Those with psychiatric illness,
• Those who have undergone cervical surgery,
• Those with a history of transient ischemic attacks,

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

SBU. Ankara A.Y. Oncology Research and Training Hospital

Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of Trendelenburg position and pneumoperitonium on cerebral tissue oxygen saturation and early postoperative cognitive dysfunction (POCD) in patients undergoing laparoscopic major abdominal oncological surgery

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: August 8, 2019
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

TU (1)