척추마취 중 상지 위치와 안압 (UEP-IOP)
개방성 서혜부 탈장 수술 시 척추마취 중 상지 위치가 안압에 미치는 영향: 무작위 대조 시험
This prospective randomized controlled trial evaluated the effect of two upper extremity positions on intraocular pressure (IOP) in adult patients undergoing surgery under spinal anesthesia. Participants were randomly assigned to either an arms-at-sides position or a hands-on-chest position. IOP was measured in the right eye using an Icare ic200 rebound tonometer at predefined perioperative time points. Hemodynamic parameters, including mean arterial pressure, heart rate, and oxygen saturation, were also recorded. The primary outcome was the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position between the two upper extremity position groups.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Intraocular pressure (IOP) may be influenced by systemic hemodynamics, venous return, episcleral venous pressure, and patient positioning. Although the effects of head and body position on IOP have been investigated, the impact of upper extremity positioning during spinal anesthesia has not been clearly established. This prospective randomized controlled trial was conducted at Elazig Fethi Sekin City Hospital. Adult patients scheduled for elective surgery under spinal anesthesia were enrolled. After written informed consent, participants were randomly assigned to one of two upper extremity positions: arms positioned alongside the body or hands positioned on the chest. IOP was measured in the right eye using an Icare ic200 rebound tonometer. Measurements were obtained at baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before application of the assigned upper extremity position, and 30 minutes after application of the assigned position (approximately 45 minutes after spinal anesthesia). Head and neck position was maintained neutral throughout the measurement period. Hemodynamic parameters, including mean arterial pressure, heart rate, and peripheral oxygen saturation, were recorded simultaneously. The primary outcome was the between-group comparison of the change in IOP from baseline to 30 minutes after application of the assigned upper extremity position. Secondary outcomes included IOP change at 15 minutes and perioperative hemodynamic changes.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Outside of the US
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Elâzığ, Outside of the US, 터키 (Türkiye), 23200
- Elazığ Fethi Sekin City Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 18 and 80 years
- ASA physical status I-III
- Scheduled for elective open inguinal hernia repair under spinal anesthesia
- Ability to undergo intraocular pressure measurement
- Provision of written informed consent
Exclusion Criteria:
- History of glaucoma or ocular hypertension
- Previous ocular surgery or ocular trauma
- Active ocular disease or infection
- Contraindication to spinal anesthesia
- Inability to cooperate with intraocular pressure measurements
- Refusal to participate
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Arms-at-Sides Position
Participants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both arms were positioned alongside the body, parallel to the torso, with the palms facing upward, and this position was maintained for approximately 30 minutes until the final T45 measurement. |
Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement. |
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실험적: Hands-on-Chest Position
Participants underwent spinal anesthesia. After the T15 intraocular pressure measurement, both upper extremities were adducted with the elbows flexed, and the open hands were placed one over the other on the anterior chest wall. This position was maintained for approximately 30 minutes until the final T45 measurement. |
Participants were assigned to one of two upper extremity positions after the T15 intraocular pressure measurement: arms positioned alongside the body or hands positioned over the chest. The assigned position was maintained for approximately 30 minutes until the final T45 intraocular pressure measurement. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Intraocular Pressure From Baseline to 30 Minutes
기간: Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. The primary outcome was the change in intraocular pressure from baseline before spinal anesthesia to 30 minutes after application of the assigned upper extremity position between the two study groups. |
Baseline before spinal anesthesia and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Intraocular Pressure From Baseline to 15 Minutes
기간: Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position
|
Intraocular pressure was measured in the right eye using an Icare ic200 rebound tonometer. This secondary outcome was the change in intraocular pressure from baseline to 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position, between the two study groups. |
Baseline before spinal anesthesia and 15 minutes after spinal anesthesia, immediately before application of the assigned upper extremity position
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Mean Arterial Pressure
기간: Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
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Mean arterial pressure was recorded simultaneously with the intraocular pressure measurements and evaluated between the two study groups. |
Baseline before spinal anesthesia, 15 minutes after spinal anesthesia immediately before positioning, and 30 minutes after application of the assigned upper extremity position (approximately 45 minutes after spinal anesthesia)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- EFSH-ANES-IOP-RCT-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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