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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07488078
Enrollment
380
Registered
2026-03-23
Start date
2025-12-01
Completion date
2026-07-28
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy

Brief summary

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

DRUGLactated Ringer 500ml

500ml ringer lactate perioperatively given in laparoscopic cholecystectomy patients as compared to traditional 1000ml fluid

DRUGLactated Ringer 1000ml

1000ml iv fluid given perioperatively in laparoscopic cholecystectomy

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Systolic Blood PressureDay 1Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively

Secondary

MeasureTime frameDescription
Mean Pulse Rate Per MinuteDay 1Mean pulse rate per minute at pre operative, 3,6,12 and 24 hours post operatively
Mean Diastolic Blood PressureDay 1Mean diastolic blood pressure at pre operative, 3,6,12 and 24 hours post operatively
Mean Pulse PressureDay 1Mean pulse pressure at pre operative, 3,6,12 and 24 hours post operatively

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026