Diastolic Shock Index for Predicting Postspinal Hypotension
2026年8月11日 更新者：İlke Dolgun、Istinye University
Comparison of the Diagnostic Performance of the Diastolic Shock Index and Other Shock Indices in Predicting Postspinal Hypotension
This prospective observational study aims to evaluate the diagnostic performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare its performance with other shock indices, including the Shock Index, Modified Shock Index, and Age Shock Index.
The study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia.
Hemodynamic parameters will be recorded before and after spinal anesthesia as part of routine clinical monitoring.
The primary outcome is the development of postspinal hypotension.
Secondary outcomes include vasopressor requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated shock indices using receiver operating characteristic curve analysis.
No additional intervention beyond routine anesthetic and perioperative care will be performed for study purposes.
調査の概要
詳細な説明
This prospective observational study will include patients aged 50 years and older undergoing elective unilateral inguinal hernia surgery under spinal anesthesia.
The study aims to evaluate the performance of the preoperative Diastolic Shock Index in predicting postspinal hypotension and to compare it with the Shock Index, Modified Shock Index, and Age Shock Index.
Baseline systolic, diastolic, and mean arterial pressures and heart rate will be recorded before spinal anesthesia and used to calculate the four shock indices.
Hemodynamic parameters will also be recorded at 5, 10, 15, and 20 minutes after spinal anesthesia as part of routine clinical monitoring, without any additional intervention for research purposes.Postspinal hypotension will be defined as a decrease in systolic arterial pressure of at least 25% from baseline and/or a systolic arterial pressure below 90 mmHg.
The primary outcome will be postspinal hypotension, while secondary outcomes will include ephedrine requirement, total ephedrine dose, lowest intraoperative mean arterial pressure, and the diagnostic performance of the evaluated indices.
Receiver operating characteristic curve analysis will be used to compare the indices and determine the optimal cut-off value for the Diastolic Shock Index, with a minimum of 85 patients planned for inclusion.
研究の種類
観察的
入学 (推定)
85
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。
研究連絡先
- 名前：ilke dolğun
- 電話番号：5555485632
- メール：ilkeser2004@gmail.com
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
The study population will consist of patients aged 50 years and older who are scheduled to undergo elective unilateral inguinal hernia surgery under spinal anesthesia at the University of Health Sciences Haseki Training and Research Hospital.
Eligible patients with American Society of Anesthesiologists physical status I-III who provide written informed consent will be included.
A minimum of 85 patients is planned for enrollment.
説明
Inclusion Criteria:
- Age 50 years or older
- Scheduled for elective unilateral inguinal hernia surgery
- Scheduled to undergo surgery under spinal anesthesia
- American Society of Anesthesiologists physical status I-III
- Provision of written informed consent
Exclusion Criteria:
- Refusal to participate in the study
- Emergency surgery
- Bilateral inguinal hernia surgery
- Contraindication to spinal anesthesia
- Failure of spinal anesthesia or conversion to general anesthesia due to failed spinal block
- Requirement for additional general anesthesia or deep sedation during surgery
- Operation duration exceeding 120 minutes
- Atrial fibrillation, atrial flutter, frequent ventricular ectopy, or other arrhythmias preventing reliable heart rate assessment
- Presence of a permanent cardiac pacemaker
- Severe valvular heart disease
- New York Heart Association class III-IV heart failure
- Preoperative use of vasopressor or inotropic therapy
- Severe hepatic failure or end-stage renal disease
- Neurological disease that may significantly affect autonomic nervous system function
- Preoperative hemodynamic instability, defined as systolic arterial pressure <90 mmHg or >180 mmHg, or heart rate <50 or >120 beats/min
- Missing study data or inability to obtain records in accordance with the study protocol
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients Who Develop Postspinal Hypotension
Patients who develop postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.
|
Spinal anesthesia will be administered as part of routine clinical care for elective unilateral inguinal hernia surgery.
The study will not modify the anesthetic management or introduce any additional intervention for research purposes.
Hemodynamic parameters obtained during routine perioperative monitoring will be recorded to evaluate the development of postspinal hypotension.
|
|
Patients Who Do Not Develop Postspinal Hypotension
Patients who do not develop postspinal hypotension, defined as the absence of a decrease in systolic arterial pressure of 25% or more from baseline and a systolic arterial pressure remaining at or above 90 mmHg following spinal anesthesia.
|
Spinal anesthesia will be administered as part of routine clinical care for elective unilateral inguinal hernia surgery.
The study will not modify the anesthetic management or introduce any additional intervention for research purposes.
Hemodynamic parameters obtained during routine perioperative monitoring will be recorded to evaluate the development of postspinal hypotension.
|
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 |
|---|---|---|
|
Development of Postspinal Hypotension
時間枠：Within the first 20 minutes after spinal anesthesia
|
Occurrence of postspinal hypotension, defined as a decrease in systolic arterial pressure of 25% or more from baseline and/or a systolic arterial pressure below 90 mmHg following spinal anesthesia.
|
Within the first 20 minutes after spinal anesthesia
|
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。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
- Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
- Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vasquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
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 (推定)
2026年8月21日
一次修了 (推定)
2027年2月21日
研究の完了 (推定)
2027年3月7日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月11日
最初の投稿 (実際)
2026年8月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月14日
QC基準を満たした最後の更新が送信されました
2026年8月11日
最終確認日
2026年8月1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。