The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function

Not Applicable

Completed

• Conditions: Response to Hyperoxia; Hypocapnia
• Interventions: Procedure: mechanical ventilation

• Registration Number: NCT02267031
• Lead Sponsor: Northern State Medical University

Brief Summary

Abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. However, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.

Detailed Description

The moderate hyperventilation resulting in hypocapnia as well as hyperoxia are common features of mechanical ventilation during general anesthesia. While mild hyperventilation is routinely advocated in laparoscopic surgical interventions, increased FiO2 is set to reinforce safety of respiratory support. Hypocapnia may cause disturbances of cerebral blood flow due to narrowing of cerebral vessels and a decrease cerebral blood flow. Hypocapnia is particularly injurious to the brain in premature infants. Factors that may predispose the immature brain to such injury include poorly developed vascular supply to vulnerable areas, antioxidant depletion by excitatory amino acids, and the lipopolysaccharide and cytokine effects that potentiate destruction of white matter. Data from neonates clearly suggest that severe hypocapnia after hyperventilation contribute to adverse neurologic outcomes. The use of high concentrations of oxygen can lead to a number of events such as the formation of harmful free radicals and activation of lipid peroxidation, resulting in secondary brain injury due to hyperoxia, particularly after suffering anoxia of the brain in resuscitated victims of sudden cardiac arrest. It is recommended to use the fraction of oxygen to maintain saturation at the level of 94-98% when performing cardiopulmonary resuscitation (CPR), due to the risk of reperfusion injury. These disturbances of gas exchange, yet transient can interfere in cerebral blood flow and therefore mental functions.

The primary aim of this study was the assessment of the impact of intraoperative gas exchange (hypocapnia, hyperoxia and their combinations) on the state of higher nervous activity

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-17
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• Informed consent
• Age > 18 years and below 80 yrs
• Elective abdominal endoscopic intervention

Exclusion Criteria

• Known cerebral disorder, incl. traumatic injury and severe vascular impairment
• Known psychiatric illness
• Severe drug or alcohol abuse
• Resent stroke (during last 6 months)
• Pregnancy
• Within the 30 days prior to this study, either entry into any other randomized therapeutic study of an agent not licensed for the intended use or administration of any other investigational agent for the treatment of ALI. Patients must not participate in such studies for at least 30 days after enrolment into this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyperoxia and normocapnia	mechanical ventilation	Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg
normoxia and hypocapnia	mechanical ventilation	Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
normoxia and normocapnia	mechanical ventilation	Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg
hyperoxia-hypocapnia	mechanical ventilation	Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg

Primary Outcome Measures

Name	Time	Method
Cognitive function	36 hrs	Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)

Secondary Outcome Measures

Name	Time	Method
Psychological Changes	6 months	Using developed phone query (memory, cognition, anxiety etc.)
Pain perception	36 hrs	Using Visual Analog Score (VAS)

Trial Locations

Locations (1)

City hospital # 1 / Northern State Medical University,; 🇷🇺 Arkhangelsk, Russian Federation