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

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ClinicalTrials.gov Identifier: NCT02267031
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : September 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Response to Hyperoxia Hypocapnia Procedure: mechanical ventilation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function: a Randomized Clinical Study
Study Start Date : October 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Active Comparator: normoxia and normocapnia
Normoxia PaO2 of 70-140 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Procedure: 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.


Active Comparator: hyperoxia and normocapnia
Hyperoxia 150-300 mm Hg Normocapnia PaCO2 of 35-48 mmHg
Procedure: 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.


Active Comparator: normoxia and hypocapnia
Normoxia PaO2 of 70-140 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Procedure: 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.


Active Comparator: hyperoxia-hypocapnia
Hyperoxia 150-300 mm Hg Hypocapnia PaCO2 of 25-35 mmHg
Procedure: 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.





Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 36 hrs ]
    Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA)


Secondary Outcome Measures :
  1. Psychological Changes [ Time Frame: 6 months ]
    Using developed phone query (memory, cognition, anxiety etc.)

  2. Pain perception [ Time Frame: 6 hrs ]
    Using Visual Analog Score (VAS)

  3. Pain perception [ Time Frame: 36 hrs ]
    Using Visual Analog Score (VAS)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267031


Locations
Russian Federation
City hospital # 1 / Northern State Medical University,
Arkhangelsk, Russian Federation, 163001
Sponsors and Collaborators
Northern State Medical University
Investigators
Principal Investigator: Mikhail Y. Kirov, MD, PhD Northern State Medical University

Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT02267031     History of Changes
Other Study ID Numbers: AC-2012
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Northern State Medical University:
cognitive dysfunction
mechanical ventilation
hyperoxia
hypocapnia

Additional relevant MeSH terms:
Hyperoxia
Hypocapnia
Signs and Symptoms, Respiratory
Signs and Symptoms