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高齢患者における単肺換気持続時間および術中脳酸素化が認知機能と術後疼痛に及ぼす影響

2026年11月2日 更新者:Ramazan Baldemir、Ankara Ataturk Sanatorium Training and Research Hospital

単肺換気時間および術中脳酸素化が、単肺換気を受ける高齢患者の認知機能と術後疼痛に及ぼす影響;前向き観察研究

One lung ventilation (OLV) is commonly used in thoracic surgery. Although the lack of ventilation of the lung in the surgical area (independent lung) during OLV redirects pulmonary blood flow to the dependent lung, shunt development is inevitable, and consequently, hypoxia is a frequently encountered condition. Therefore, one of the most important aspects that clinicians pay attention to during OLV is cerebral oxygen saturation in addition to peripheral oxygenation monitoring.

Studies have shown a correlation between decreased cerebral oxygen saturation and postoperative cognitive dysfunction (POCD). Patients undergoing OLV are also at risk of cerebral desaturation due to this non-physiological ventilation.

Patients undergoing OLV are at risk of cerebral oxygen desaturation. Therefore, in these patients, both cognitive dysfunction and changes in brain oxygenation can negatively affect pain-related centers, altering pain perception. Geriatric patients are particularly more affected by these negative effects. It is generally accepted by healthcare professionals specializing in pain management that the application of pain management should differ for elderly patients compared to younger patients. Analgesic dose adjustment should be done more carefully in geriatric patients. Increased sensitivity to opioids due to hypoxia can cause respiratory depression and increased analgesic effects. To avoid these, opioid dose adjustment is necessary in these patients. In conclusion, cerebral oxygen saturation measurement can be an effective method to detect cerebral oxygen desaturation, especially in the geriatric patient group. In this way, the effect of hypoxia caused by OLV on cerebral oxygen saturation can be detected early, and POCD can be limited. We believe that this situation can also contribute to effective postoperative pain management. This study aimed to investigate the effect of intraoperative brain oxygenation on cognitive function and postoperative pain in geriatric patients who underwent OLV.

MATERİAL AND METHODS This study will be conducted in accordance with the Helsinki Declaration and will take place at Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital . The study will be planned for geriatric patients over 65 years of age with a high school diploma or higher education level who have given informed consent and are scheduled for OLV with standard anesthesia monitoring. These patients, undergoing thoracic surgery via thoracotomy and who agree to participate in this study and sign an informed consent form, will be prospectively enrolled. A total of 30 patients will be included in our study. Preoperatively, patients will undergo standard monitoring including non-invasive arterial blood pressure, electrocardiography, and peripheral oxygen saturation (SpO2). Cerebral oxygenation of patients who have signed an informed consent form the day before will be recorded throughout the surgical procedure using probes placed on the forehead before the induction of anesthetic drugs.

The standard anesthesia and analgesia protocol that we routinely apply to patients will be applied throughout the surgery. Routine preoperative blood tests, age, height, weight, Body Mass Index (BMI), gender, diagnosis, preoperative comorbidities (hypertension, diabetes, coronary artery disease, chronic obstructive pulmonary disease, etc.), previous surgeries (any surgical procedure performed under general anesthesia before this study), American Society of Anesthesiologists ( ASA) score, and duration of surgery will be recorded for each patient. Hemodynamic data (systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), pulse, SpO2, and cerebral oxygen saturation will be recorded before anesthesia induction, after induction, and at 5, 10, 20, 30, and 60 minutes after the start of OLV. These hemodynamic data will also be recorded at the end OLV and at the end of the operation. OLV duration, anesthesia duration, surgery duration, amount of fluid administered, urine output, and whether blood replacement was performed will be recorded. Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively. Analgesic medications administered during the 24-hour postoperative period will also be recorded. VAS evaluation will be performed on a 100 mm scale, where 0: no pain and 100: maximum pain, indicating the patient's pain level. During this process, any possible side effects that may develop due to analgesic treatment will be recorded.

The Mini Mental Test (MMT) form will be completed by patients one day before surgery, 48 hours postoperatively, on the 7th day postoperatively. MMT consists of eleven items grouped under five main headings: Orientation, recording memory, attention and calculation, recall, and language, and is evaluated out of a total score of 30.

調査の概要

詳細な説明

H0: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have no effect on cognitive function.

H1: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have an effect on cognitive function.

H0: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have no effect on postoperative pain.

H1: In geriatric patients with a high school diploma or higher education level who are undergoing single-lung ventilation, single-lung ventilation duration and intraoperative brain oxygenation have an effect on postoperative pain.

研究の種類

観察的

入学 (推定)

30

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Ankara、トルコ(Türkiye)
        • Ankara Ataturk Sanatorium Training and Research Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

This study will be conducted in accordance with the Helsinki Declaration and will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital after obtaining ethical committee approval. The study will be planned for geriatric patients over 65 years of age with a high school diploma or higher education level who have given informed consent and are scheduled for single-lung ventilation (TAV) with standard anesthesia monitoring

説明

Inclusion Criteria:

  • Patients aged 65 and over with a high school diploma or higher education
  • Patients undergoing lung resection via thoracotomy (wedge resection, lingulectomy, segmentectomy, lobectomy, pneumonectomy)
  • American Society of Anesthesiologists (ASA) score I-II-III,
  • Body mass index (BMI) between 18-40 kg/m2,
  • Patients undergoing surgery under general anesthesia will be included in the study.

Exclusion Criteria:

  • Patients under 65 years of age, patients over 65 who are illiterate,
  • Who have completed primary or secondary school,
  • Patients with pre-existing cognitive impairment confirmed by preoperative Mini Mental State Examination (MMSE),
  • Patients with a history of previously diagnosed mental illness, cerebrovascular disease, senile dementia, stroke,
  • Patients using continuous anti-inflammatory/analgesic medications,
  • Patients with preoperative chronic pain,
  • Severe cardiovascular disease,
  • Diagnosed neurological and psychiatric diseases,
  • Patients allergic to the anesthetic and analgesic drugs to be administered,
  • Patients with severe renal failure, gastrointestinal ulceration or severe asthma that prevents the administration of standard analgesia protocols,
  • Patients undergoing surgery other than lung resection,
  • Patients undergoing surgery with TIVA (total intravenous anesthesia) will be excluded from the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:COHORT
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
Patients over 65 years of age who will undergo single-lung ventilation with thoracotomy.

The duration of single-lung ventilation and cerebral oxygenation values administered to patients during the intraoperative period will be recorded. The effects of these values on postoperative cognitive function and pain will be analyzed using statistical methods.

One day before the operation, postoperative The Mini Mental Test (MMT) form will be completed by patients at 48 hours and on the 7th postoperative day

Pain levels of patients at 1, 2, 4, 8, 16, and 24 hours after thoracotomy will be evaluated using the Visual Analog Scale (VAS)

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
ミニメンタルテスト測定
時間枠:手術前24時間、手術後48時間、および術後7日目、または退院7日前、または退院直前に。
手術前24時間、手術後48時間、および術後7日目、または退院7日前、または退院直前に。
ミニメンタルテスト測定
時間枠:手術前24時間、手術後48時間、および術後7日目、または退院日が7日未満の場合は退院直前に。
手術前24時間、手術後48時間、および術後7日目、または退院日が7日未満の場合は退院直前に。

二次結果の測定

結果測定
メジャーの説明
時間枠
Visual Analog Scale (VAS) scores
時間枠:Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively

During VAS evaluation, the patient will be asked to indicate the location of their pain intensity on a 100 mm scale (0: no pain, 100: maximum pain),

Visual Analog Scale (VAS) scores will be recorded at 1, 2, 4, 8, 16, and 24 hours postoperatively

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Fatma Öztürk Yalçın、ANKARA ATATURK SANATORİUM TRAİNİNG AND RESEARCH HOSPITAL

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月15日

一次修了 (推定)

2027年3月15日

研究の完了 (推定)

2027年5月30日

試験登録日

最初に提出

2026年1月5日

QC基準を満たした最初の提出物

2026年1月5日

最初の投稿 (実際)

2026年1月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年1月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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