Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
Observational Study of Cerebral Oxygenation and Spinal Anaesthesia in Elderly Patients With Hip Fracture
調査の概要
詳細な説明
Patients aged 70 years old with hip fracture presenting for surgical repair under intrathecal anaesthesia performed with bupivacaine or L bupivacaine (dose 7 - 9 mg). Preoperative haemoglobin and drugs consumption are registered. All patients receive supplemental oxygen during surgery. Cerebral oximetry, blood pressure, heart rate and oxygen arterial saturation are measured. Level and duration of sensory and motor block are registered. The study observes if there is any correlation between cerebral oximetry and these hemodynamic parameters.
The investigators also observe if there is any correlation between cerebral oximetry and cognitive function evaluated pre and postoperatively by SPMSQ test.
Postoperative SPMSQ test will be performed on the 5th postoperative day and the complications registered.Patients will be followed for the duration of acute hospital stay.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Sabadell
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Barcelona、Sabadell、スペイン、08208
- 募集
- Hospital de Sabadell - CSPT
-
コンタクト：
- Diana L Fernández Galinski, PhD
- 電話番号：21277 0034937231010
- メール：DFernandez@tauli.cat
-
コンタクト：
- Francisca Gordo Lacal, Dr
- 電話番号：21277 0034937231010
- メール：fgordo@tauli.cat
-
主任研究者：
- Diana L Fernández Galinski, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
- Patients aged >70 years old with hip fracture.
- No contraindication for spinal anaesthesia.
Exclusion Criteria:
- Allergic reaction to local anesthetics.
- Severe aortic stenosis.
- Local infection.
- SPMSQ test >7 errors.
- Patient refusal
研究計画
研究はどのように設計されていますか？
デザインの詳細
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cerebral Oximetry
時間枠：Initial, 3 times after spinal block and every 10 minutes during surgery
|
Changes in cerebral oxymetry measured initially (basal), 10, 20 and 30 minutes after spinal block.
During surgery oximetry is measured evey 10 minutes to obtain the mean of all the values.
|
Initial, 3 times after spinal block and every 10 minutes during surgery
|
|
Mean Arterial Pressure (MAP)
時間枠：Initial, 3 times after spinal block and every 10 minutes during surgery
|
Changes in MAP measured initially (basal), 10, 20 and 30 minutes after spinal block.
During surgery oximetry is measured every 10 minutes to obtain the mean of all the values
|
Initial, 3 times after spinal block and every 10 minutes during surgery
|
|
Heart Rate (HR)
時間枠：Initial, 3 times after spinal block and every 10 minutes during surgery
|
Changes in HR (basal), 10, 20 and 30 minutes after spinal block.
During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
|
Initial, 3 times after spinal block and every 10 minutes during surgery
|
|
Oxygen arterial saturation (OSat)
時間枠：Initial, 3 times after spinal block and every 10 minutes during surgery
|
Changes in OSat measured initially (basal), 10, 20 and 30 minutes after spinal block.
During surgery oximetry is measured every 10 minutes to obtain the mean of all the values.
|
Initial, 3 times after spinal block and every 10 minutes during surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Short Portable Mental Status Questionnaire (SPMSQ)
時間枠：Once before surgery and at 5th postoperative day
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This test measures cognitive impairment before and after surgery
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Once before surgery and at 5th postoperative day
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Diana L Fernández Galinski, PhD、Hospital de Sabadell - CSPT
研究記録日
主要日程の研究
研究開始
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。