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

NCT ID: NCT02267031

Last Updated: 2016-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-08-31

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

Conditions

Response to Hyperoxia; Hypocapnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

normoxia and normocapnia

Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg

Group Type: ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type: PROCEDURE

Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).

Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.

hyperoxia and normocapnia

Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg

Group Type: ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type: PROCEDURE

Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).

Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.

normoxia and hypocapnia

Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg

Group Type: ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type: PROCEDURE

Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).

Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.

hyperoxia-hypocapnia

Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg

Group Type: ACTIVE_COMPARATOR

mechanical ventilation

Intervention Type: PROCEDURE

Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).

Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.

Interventions

mechanical ventilation

Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).

Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikhail Y. Kirov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northern State Medical University

Locations

City hospital # 1 / Northern State Medical University,

Arkhangelsk, , Russia

Countries

Russia

Other Identifiers

AC-2012

Identifier Type: -

Identifier Source: org_study_id