- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07563530
Early Oral Hydration in Relieving Postoperative Thirst
Effectiveness of Early Oral Hydration in Relieving Postoperative Thirst in Patients Undergoing Urological Endoscopic Procedures: A Randomized Controlled Trial
연구 개요
상태
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muhammad M Abbas, FCPS
- 전화번호: 02199215718
- 이메일: smabbas69@hotmail.com
연구 장소
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Sindh
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Karachi, Sindh, 파키스탄, 74200
- 모병
- Sindh Institute of Urology and Transplantation
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연락하다:
- Muhammad M Abbas, FCPS
- 전화번호: +923331318838
- 이메일: smabbas69@hotmail.com
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부수사관:
- Love Khatri, IMM
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male and female patients aged 18-65 years.
- Scheduled for elective urological endoscopic procedures under general anesthesia.
- Day-care endoscopic procedures.
- ASA classification I-III.
Exclusion Criteria:
- Known gastrointestinal disorders contraindicating early oral hydration (e.g., peptic ulcer disease, hiatal hernia, irritable bowel syndrome, esophagitis, or prior gastrointestinal surgery).
- Inability to express thirst or communicate (e.g., language barrier, altered consciousness).
- Requirement for nasogastric suction.
- History of facial, oropharyngeal, or laryngeal surgery.
- Swallowing dysfunction or delayed gastric emptying (e.g., gastroparesis).
- Incomplete reversal of muscle relaxant at PACU admission (no adequate spontaneous breathing or protective airway reflexes).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: EOH Group (Early Oral Hydration)
Patients in the intervention group will be allowed early oral hydration on demand upon admission to the PACU if they meet the following safety criteria. Practical PACU checklist to be fulfilled before giving plain water. Require all of the following before any oral intake (start with small sips, e.g., 10 ml): |
"Early oral hydration" refers to the administration of small sips of water (maximum 10 mL initially) within 15-30 minutes of arrival in the PACU, once the patient is fully conscious, stable, and meets safety criteria. Initially, patients will be provided a maximum of 10 mL of water using a straw. After this initial intake, they will be allowed to drink water according to their demand, provided their condition remains stable. To minimize the risk of adverse events such as regurgitation and aspiration, the total amount of water intake will be restricted to 0.5 mL/kg. |
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활성 비교기: Control Group (Standard PACU Protocol)
Patients in the control group will follow the standard PACU protocol, which will delay oral hydration for 2-3 hours after the end of anesthesia.
During this period, patients will be monitored closely for thirst and other postoperative symptoms.
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Patients in the control group will follow the standard PACU protocol, which will delay oral hydration for 2-3 hours after the end of anesthesia.
During this period, patients will be monitored closely for thirst and other postoperative symptoms.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Thirst intensity upon PACU arrival
기간: Up to 2 hours during immediate post-operative period
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Patients will be asked Did you experience thirst upon arrival in the PACU?
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Up to 2 hours during immediate post-operative period
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Thirst intensity at PACU discharge
기간: Up to 2 hours during immediate post-operative period
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Patients will be asked Did you experience thirst at PACU discharge?
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Up to 2 hours during immediate post-operative period
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Patient comfort
기간: Up to 2 hours during immediate post-operative period
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Rate your comfort level during the PACU stay using the VAS (0-10) (0 = Uncomfortable, 10 = Very comfortable) [0---1---2---3---4---5---6---7---8---9---10] |
Up to 2 hours during immediate post-operative period
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Patient satisfaction with the hydration timing.
기간: Up to 2 hours during immediate post-operative period
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How satisfied are you with the hydration timing? (5-point Likert Scale):
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Up to 2 hours during immediate post-operative period
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Patient satisfaction with the hydration procedure.
기간: Up to 2 hours during immediate post-operative period
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How satisfied are you with the hydration process overall? (5-point Likert Scale):
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Up to 2 hours during immediate post-operative period
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Total oral water intake (mL) during PACU stay.
기간: Up to 2 hours iduring immediate post-operative period
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The total amount of water intake will be restricted to 0.5 mL/kg. The water will be provided in a graduated cup, and the total water intake will be calculated as follows: Total Water Intake (mL) = Volume of water in the cup upon PACU admission - Volume of water remaining in the cup upon PACU discharge. |
Up to 2 hours iduring immediate post-operative period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse Events
기간: Up to 2 hours during immediate post-operative period
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Do you experience any of the following adverse events after drinking water? (Check all that apply):
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Up to 2 hours during immediate post-operative period
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Medical intervention given for any adverse event
기간: Up to 2 hours during immediate post-operative period
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Is medical intervention given for any adverse event?
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Up to 2 hours during immediate post-operative period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Muhammad M Abbas, FCPS, Sindh Institute of Urology and Transplantation
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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