- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Muhammad M Abbas, FCPS
- Telefonnummer: 02199215718
- E-Mail: smabbas69@hotmail.com
Studienorte
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Sindh
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Karachi, Sindh, Pakistan, 74200
- Rekrutierung
- Sindh Institute of Urology and Transplantation
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Kontakt:
- Muhammad M Abbas, FCPS
- Telefonnummer: +923331318838
- E-Mail: smabbas69@hotmail.com
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Unterermittler:
- Love Khatri, IMM
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Thirst intensity upon PACU arrival
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Adverse Events
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Muhammad M Abbas, FCPS, Sindh Institute of Urology and Transplantation
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SIUT-ERC-2025/A-586
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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