Effect of Liberal Versus Restrictive Intravenous Fluid Administration on Postoperative Homeostasis in Patients Undergoing Laparoscopic Cholecystectomy
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Mean Systolic Blood Pressure
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Mean Systolic Blood Pressure
Time Frame: Day 1
Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively
Secondary Outcomes
- Mean Pulse Rate Per Minute(Day 1)
- Mean Diastolic Blood Pressure(Day 1)
- Mean Pulse Pressure(Day 1)