The Effect of Neostigmine and Sugammadex on the Optic Nerve Sheath Diameter
Comparison of the Effects of Neostigmine and Sugammadex on the Optic Nerve Sheath Diameter During the Postoperative Extubation Period
調査の概要
詳細な説明
The study will be conducted prospectively, randomly, and double-blind on a total of 86 patients aged 18-65 years, classified as ASA 1-2, undergoing elective surgery at the Department of Anesthesiology and Reanimation, Faculty of Medicine, Çukurova University. Written and verbal informed consent will be obtained from all participants prior to the study.
The demographic data, such as age, gender, body weight, and height, as well as ASA score and information on comorbidities, will be recorded for the patients included in the study in the preoperative anesthesia care unit. All patients who will be taken to the operating room without premedication will undergo routine monitoring, including electrocardiography, noninvasive blood pressure monitoring, and peripheral oxygen saturation. During induction of anesthesia, propofol IV 2 mg/kg, rocuronium IV 0.6 mg/kg, and fentanyl IV 1 mcg/kg will be used. After observing adequate muscle relaxation with a TOF (Train-of-Four) monitor, tracheal intubation will be performed. All patients will receive mechanical ventilation after intubation. During anesthesia, a gas mixture of 2% sevoflurane, 60% nitrous oxide, and 40% oxygen will be administered at a flow rate of 2 L/min. To maintain muscle relaxation throughout the surgery, when a TOF of 2 is observed, 0.2 mg/kg of rocuronium IV will be administered. Tramadol 2 mg/kg IV will be given 45 minutes before the end of surgery for postoperative pain management. Ondansetron 8 mg IV will be planned as antiemetic treatment. At the end of the surgery, the maintenance gases will be discontinued, and according to the randomization, the anesthesiologist responsible for anesthesia administration will either administer 2 mg/kg Sugammadex IV or 0.05 mg/kg Neostigmine IV plus 0.02 mg/kg atropine sulfate IV. Patients who show a TOF value of 90% and clinically adequate respiration will be extubated.
In addition to the anesthesiologist responsible for administering anesthesia, one blinded evaluator for each group will perform three ultrasound measurements on both eyes to determine the Optic nerve sheath diameter at 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation. The measurements will be recorded while the patient is in a supine position, with ultrasound gel applied to the eyelid, using a linear probe without applying pressure to the eyeball.
The diameter of the optic nerve sheath will be systematically measured at a point 3.0 mm posterior to the optic disc to ensure consistent anatomical evaluation.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Ersel Gulec, MD
- 電話番号：3289 +903223386060
- メール：gulecersel@yahoo.com
研究場所
-
-
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Adana、トルコ（Türkiye）
- 募集
- Cukurova University Faculty of Medicine
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主任研究者：
- Ersel Gulec, MD
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副調査官：
- Mediha Turktan, MD
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副調査官：
- Zehra Hatipoglu, MD
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副調査官：
- Dilek Ozcengiz, MD
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コンタクト：
- Ersel Gulec, MD
- 電話番号：3289 +903223386060
- メール：gulecersel@yahoo.com
-
副調査官：
- Kubra Gunsur, MD
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副調査官：
- Demet Lafli Tunay, MD
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-
参加基準
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
説明
Inclusion Criteria:
- With an ASA physical status of 1-2
- Patients scheduled for elective surgery
- Patients willing to participate in the study
Exclusion Criteria:
- Patients with heart, liver, kidney, or respiratory failure
- Brain tumors, hemorrhages, or aneurysms
- Patients who have undergone eye, cardiovascular, or neurosurgery
- Eye or neurological diseases or increased intracranial pressure
- Laparoscopic surgeries
- Cases not in the supine position
- Allergy to the medications used
- Patients who did not provide informed consent to participate in the study.
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group S
Sugammadex, intravenous, 2 mg/kg, single bolus dose.
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Intravenous bolus injection
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|
アクティブコンパレータ：Group N
Neostigmine, intravenous, 0.05 mg/kg, single bolus dose.
Atropine sulfate, intravenous, 0.02 mg/kg, single bolus dose.
|
Intravenous bolus injection
|
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 |
|---|---|---|
|
Change in average optic nerve sheath diameter from intubation to the 5th minute after extubation
時間枠：From the time of endotracheal intubation until 5 minutes after extubation
|
Three measurements will be taken for each eye using ultrasound to determine the diameter of the optic nerve sheath at 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation; the average values for each eye will be recorded.
Subsequently, the averages of the measurements obtained for both eyes will be calculated.
Changes in these averages over time will be compared between groups.
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From the time of endotracheal intubation until 5 minutes after extubation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Pressure
時間枠：From the time of endotracheal intubation until 5 minutes after extubation
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Blood pressure will be measured and recorded 5 minutes after endotracheal intubation, 5 minutes before extubation, and 5 minutes after extubation
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From the time of endotracheal intubation until 5 minutes after extubation
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Postoperative nausea and vomiting
時間枠：The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit.
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The number of patients who experienced nausea and vomiting upon waking from anesthesia and during their stay in the postoperative care unit.
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The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit.
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Blood pressure
時間枠：The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit.
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Noninvasive measurement of blood pressure
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The one-hour period from endotracheal tube removal to patient discharge from the postoperative care unit.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ersel Gulec, MD、Cukurova University
出版物と役立つリンク
一般刊行物
- Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.
- Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
- P S L, Miskan MM, Y Z C, Zaki RA. Staggering the dose of sugammadex lowers risks for severe emergence cough: a randomized control trial. BMC Anesthesiol. 2017 Oct 11;17(1):137. doi: 10.1186/s12871-017-0430-3.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25-AKD-309
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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