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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Ersel Gulec, MD
- 전화번호: 3289 +903223386060
- 이메일: gulecersel@yahoo.com
연구 장소
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Adana, 터키 (Türkiye)
- 모병
- Cukurova University Faculty of Medicine
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수석 연구원:
- Ersel Gulec, MD
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부수사관:
- Mediha Turktan, MD
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부수사관:
- Zehra Hatipoglu, MD
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부수사관:
- Dilek Ozcengiz, MD
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연락하다:
- Ersel Gulec, MD
- 전화번호: 3289 +903223386060
- 이메일: gulecersel@yahoo.com
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부수사관:
- Kubra Gunsur, MD
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부수사관:
- Demet Lafli Tunay, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Group S
Sugammadex, intravenous, 2 mg/kg, single bolus dose.
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Intravenous bolus injection
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활성 비교기: Group N
Neostigmine, intravenous, 0.05 mg/kg, single bolus dose.
Atropine sulfate, intravenous, 0.02 mg/kg, single bolus dose.
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Intravenous bolus injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in average optic nerve sheath diameter from intubation to the 5th minute after extubation
기간: From the time of endotracheal intubation until 5 minutes after extubation
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood Pressure
기간: 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
기간: 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
기간: 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.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ersel Gulec, MD, Cukurova University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-AKD-309
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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