Early Oral Hydration in Relieving Postoperative Thirst

NCT07563530 | Recruiting DMC

• 1 other identifier: SIUT-ERC-2025/A-586
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether allowing early oral hydration on demand effectively relieves postoperative thirst and enhances patient satisfaction in individuals undergoing urological endoscopic procedures

Conditions

Patient Satisfaction; Thirst; Due to Deprivation of Water

Keywords

Postoperative; Thirst; Oral Hydration; Satisfaction

Outcome Measures

Primary Outcomes (6)

• Thirst intensity upon PACU arrival

  Patients will be asked Did you experience thirst upon arrival in the PACU? * Yes * No If yes, rate your thirst intensity upon PACU arrival using the Visual Analogue Scale (VAS) on PACU entry. 0 = No thirst, 10 = Worst imaginable thirst \[0---1---2---3---4---5---6---7---8---9---10\]

  Up to 2 hours during immediate post-operative period

• Thirst intensity at PACU discharge

  Patients will be asked Did you experience thirst at PACU discharge? * Yes * No If yes, rate your thirst intensity at PACU discharge using the VAS (0-10). 0 = No thirst, 10 = Worst imaginable thirst \[0---1---2---3---4---5---6---7---8---9---10\]

  Up to 2 hours during immediate post-operative period

• Patient comfort

  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.

  How satisfied are you with the hydration timing? (5-point Likert Scale): * Very Dissatisfied * Dissatisfied * Neutral * Satisfied * Very Satisfied

  Up to 2 hours during immediate post-operative period

• Patient satisfaction with the hydration procedure.

  How satisfied are you with the hydration process overall? (5-point Likert Scale): * Very Dissatisfied * Dissatisfied * Neutral * Satisfied * Very Satisfied

  Up to 2 hours during immediate post-operative period

• Total oral water intake (mL) during PACU stay.

  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

Secondary Outcomes (2)

• Adverse Events

  Up to 2 hours during immediate post-operative period

• Medical intervention given for any adverse event

  Up to 2 hours during immediate post-operative period

Study Arms (2)

EOH Group (Early Oral Hydration)

EXPERIMENTAL

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):

Dietary Supplement: Early oral hydration

Control Group (Standard PACU Protocol)

ACTIVE COMPARATOR

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.

Other: No early oral hydration (As per Standard PACU Protocol)

Interventions

Early oral hydration DIETARY_SUPPLEMENT

"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.

EOH Group (Early Oral Hydration)

No early oral hydration (As per Standard PACU Protocol) OTHER

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.

Control Group (Standard PACU Protocol)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Personal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Muhammad M Abbas, FCPS

  Sindh Institute of Urology and Transplantation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad M Abbas, FCPS

CONTACT

02199215718; smabbas69@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will collect the data from the patients enrolled in this study by the primary investigator in the postanesthesia care unit once the patients are received in the postoperative ward. This data will contain demographics as well as questionnaire-based satisfaction grading and the possible adverse effects.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All eligible patients meeting the inclusion criteria will be identified preoperatively by the researcher. Written informed consent will be obtained from each participant after explaining the study purpose, procedures, possible risks, and benefits in their preferred language. Upon arrival in the PACU, patients will be randomized into Group A (early oral hydration) or Group B (control) is using sealed opaque envelopes.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: May 4, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

PA (1)