Effect of Liberal and Restrictive IV Fluids on Recovery After Gallbladder Surgery

March 17, 2026 updated by: King Edward Medical University

Effect of Liberal Versus Restrictive Intravenous Fluid Administration on Postoperative Homeostasis in Patients Undergoing Laparoscopic Cholecystectomy

The goal of this clinical trial is to learn whether giving less intravenous (IV) fluid (restrictive administration) after surgery is as effective as giving more IV fluid (liberal administration) in maintaining body stability (homeostasis) among adults undergoing laparoscopic gallbladder removal (cholecystectomy).

The main questions it aims to answer are:

Does restrictive IV fluid administration maintain stable blood pressure, heart rate, and urine output after laparoscopic cholecystectomy?

Are there any differences in postoperative recovery or complications between restrictive and liberal fluid regimens?

Researchers will compare patients receiving liberal IV fluid administration with those receiving restrictive IV fluid administration to see if both methods maintain similar postoperative homeostasis and recovery outcomes.

Participants will:

Be adults aged 18-60 years (ASA class I-II) undergoing elective laparoscopic cholecystectomy.

Be randomly assigned to one of two groups:

Group A: Liberal IV fluid administration for 6 hours after surgery.

Group B: Restrictive IV fluid administration for 6 hours after surgery.

Have their vital signs (pulse, blood pressure, mean arterial pressure) and urine output recorded at multiple time points after surgery (immediate, 3, 6, 12, and 24 hours).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • King Edward Medical University Lahore / Mayo Hospital Lahore
        • Contact:

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients undergoing elective cholecystectomy
  • Age : 18-60 years
  • All genders
  • ASA class 1 and 2

Exclusion Criteria:

  • History of previous laparotomy
  • Perforated gall bladder
  • Duration of surgery more than 3 hours
  • More than 100ml intra operative blood loss

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liberal Fluid Administration
1000ml iv fluid
Drug: Lactated Ringer 1000ml
1000ml iv fluid given perioperatively in laparoscopic cholecystectomy
Experimental: Restricted Fluid Administration
500ml iv fluid
Drug: Lactated Ringer 500ml
500ml ringer lactate perioperatively given in laparoscopic cholecystectomy patients as compared to traditional 1000ml fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Systolic Blood Pressure
Time Frame: Day 1
Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Pulse Rate Per Minute
Time Frame: Day 1
Mean pulse rate per minute at pre operative, 3,6,12 and 24 hours post operatively
Day 1
Mean Diastolic Blood Pressure
Time Frame: Day 1
Mean diastolic blood pressure at pre operative, 3,6,12 and 24 hours post operatively
Day 1
Mean Pulse Pressure
Time Frame: Day 1
Mean pulse pressure at pre operative, 3,6,12 and 24 hours post operatively
Day 1

Collaborators and Investigators

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

Sponsor

King Edward Medical University

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)

December 1, 2025

Primary Completion (Estimated)

July 28, 2026

Study Completion (Estimated)

July 28, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 335/RC/KEMU

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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