- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Muhammad M Abbas, FCPS
- Numero di telefono: 02199215718
- Email: smabbas69@hotmail.com
Luoghi di studio
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Reclutamento
- Sindh Institute of Urology and Transplantation
-
Contatto:
- Muhammad M Abbas, FCPS
- Numero di telefono: +923331318838
- Email: smabbas69@hotmail.com
-
Sub-investigatore:
- Love Khatri, IMM
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Thirst intensity upon PACU arrival
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
Patients will be asked Did you experience thirst upon arrival in the PACU?
|
Up to 2 hours during immediate post-operative period
|
|
Thirst intensity at PACU discharge
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
Patients will be asked Did you experience thirst at PACU discharge?
|
Up to 2 hours during immediate post-operative period
|
|
Patient comfort
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
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
|
|
Patient satisfaction with the hydration timing.
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
How satisfied are you with the hydration timing? (5-point Likert Scale):
|
Up to 2 hours during immediate post-operative period
|
|
Patient satisfaction with the hydration procedure.
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
How satisfied are you with the hydration process overall? (5-point Likert Scale):
|
Up to 2 hours during immediate post-operative period
|
|
Total oral water intake (mL) during PACU stay.
Lasso di tempo: Up to 2 hours iduring immediate post-operative period
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adverse Events
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
Do you experience any of the following adverse events after drinking water? (Check all that apply):
|
Up to 2 hours during immediate post-operative period
|
|
Medical intervention given for any adverse event
Lasso di tempo: Up to 2 hours during immediate post-operative period
|
Is medical intervention given for any adverse event?
|
Up to 2 hours during immediate post-operative period
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Muhammad M Abbas, FCPS, Sindh Institute of Urology and Transplantation
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SIUT-ERC-2025/A-586
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Early oral hydration
-
Oregon Health and Science UniversityNational Institute of Mental Health (NIMH); University of Connecticut; University... e altri collaboratoriNon ancora reclutamento
-
Alcon ResearchCompletatoCataratta | Malattia dell'occhio seccoSpagna
-
DongE E Jiao Coporation LimitedCompletatoOligozoospermia e Astenospermia Lieve e Moderata o Oligoastenospermia e il Tipo di Differenziazione della Sindrome è Carenza dell'Essenza del Shen (Rene)Cina
-
Universidade do PortoCentro Hospitalar De São João, E.P.E.Non ancora reclutamentoCure palliative | Leucemia mieloide acutaPortogallo
-
Universidad de MurciaCompletatoDisturbo non diabetico del pancreas endocrinoSpagna
-
Beijing Anzhen HospitalReclutamento
-
Istituto Oncologico Veneto IRCCSTerminatoAdenocarcinoma colorettaleItalia
-
Siperstein DermatologyCompletato
-
Fu Wai Hospital, Beijing, ChinaThe First Affiliated Hospital with Nanjing Medical UniversityAttivo, non reclutanteArresto cardiaco | Stimolazione del ramo del fascio sinistroCina
-
Lawson Health Research InstituteUniversity of Western Ontario, Canada; London Health Sciences Centre; Mindfulness...CompletatoDisturbi psicotici | SchizofreniaCanada