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Recruiting NCT07488078

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

Phase I Interventional Laparoscopic Cholecystectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactated Ringer 500ml, Lactated Ringer 1000ml.
Who it may be relevant to
Registry conditions: Laparoscopic Cholecystectomy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Drug Lactated Ringer 500ml
    500ml ringer lactate perioperatively given in laparoscopic cholecystectomy patients as compared to traditional 1000ml fluid
  • Drug Lactated Ringer 1000ml
    1000ml iv fluid given perioperatively in laparoscopic cholecystectomy

Primary outcome measures

  • Mean Systolic Blood Pressure [Time frame: Day 1]
Secondary outcome measures (3)
  • Mean Pulse Rate Per Minute [Time frame: Day 1]
  • Mean Diastolic Blood Pressure [Time frame: Day 1]
  • Mean Pulse Pressure [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • King Edward Medical University Lahore / Mayo Hospital Lahore — Lahore

Identifiers

NCT: NCT07488078 · 335/RC/KEMU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗