Early Oral Hydration in Relieving Postoperative Thirst

April 25, 2026 updated by: Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation

Effectiveness of Early Oral Hydration in Relieving Postoperative Thirst in Patients Undergoing Urological Endoscopic Procedures: A Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Postoperative thirst is a frequent but often overlooked discomfort experienced by patients after surgery, particularly following urological endoscopic procedures.Despite the common restriction on carly oral intake due to concerns about nausea and aspiration, delaying hydration prolongs patient suffering and reduces satisfaction during recovery. This study aims to investigate whether allowing carly, on-demand oral hydration in the postanesthesia care unit (PACU) can effectively relieve postoperative thirst without increasing adverse effects, thereby potentially improving patient comfort and outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Recruiting
        • Sindh Institute of Urology and Transplantation
        • Contact:
        • Sub-Investigator:
          • Love Khatri, IMM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and female patients aged 18-65 years.
  2. Scheduled for elective urological endoscopic procedures under general anesthesia.
  3. Day-care endoscopic procedures.
  4. ASA classification I-III.

Exclusion Criteria:

  1. Known gastrointestinal disorders contraindicating early oral hydration (e.g., peptic ulcer disease, hiatal hernia, irritable bowel syndrome, esophagitis, or prior gastrointestinal surgery).
  2. Inability to express thirst or communicate (e.g., language barrier, altered consciousness).
  3. Requirement for nasogastric suction.
  4. History of facial, oropharyngeal, or laryngeal surgery.
  5. Swallowing dysfunction or delayed gastric emptying (e.g., gastroparesis).
  6. Incomplete reversal of muscle relaxant at PACU admission (no adequate spontaneous breathing or protective airway reflexes).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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):
Dietary supplement: Early oral hydration

"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.
Active Comparator: 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.
Other: No early oral hydration (As per 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thirst intensity upon PACU arrival
Time Frame: Up to 2 hours during immediate post-operative period

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
Time Frame: Up to 2 hours during immediate post-operative period

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
Time Frame: 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.
Time Frame: Up to 2 hours during immediate post-operative period

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.
Time Frame: Up to 2 hours during immediate post-operative period

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.
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 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):

  • Bucking
  • Aspiration
  • Vomiting
  • None
Up to 2 hours during immediate post-operative period
Medical intervention given for any adverse event
Time Frame: Up to 2 hours during immediate post-operative period

Is medical intervention given for any adverse event?

  • Yes (specify: _____________)
  • No
Up to 2 hours during immediate post-operative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sindh Institute of Urology and Transplantation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad M Abbas, FCPS, Sindh Institute of Urology and Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIUT-ERC-2025/A-586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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