- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad M Abbas, FCPS
- Phone Number: 02199215718
- Email: smabbas69@hotmail.com
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Recruiting
- Sindh Institute of urology and Transplantation
-
Contact:
- Muhammad M Abbas, FCPS
- Phone Number: +923331318838
- Email: smabbas69@hotmail.com
-
Sub-Investigator:
- Love Khatri, IMM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
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. |
|
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.
|
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
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?
|
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?
|
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):
|
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):
|
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
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):
|
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?
|
Up to 2 hours during immediate post-operative period
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad M Abbas, FCPS, Sindh Institute of urology and Transplantation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIUT-ERC-2025/A-586
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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