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

NCT07488078 | Recruiting Phase 1 DMC

• 1 other identifier: 335/RC/KEMU
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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).

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Mean Systolic Blood Pressure

  Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively

  Day 1

Secondary Outcomes (3)

• Mean Pulse Rate Per Minute

  Day 1

• Mean Diastolic Blood Pressure

  Day 1

• Mean Pulse Pressure

  Day 1

Study Arms (2)

Liberal Fluid Administration

ACTIVE COMPARATOR

1000ml iv fluid

Drug: Lactated Ringer 1000ml

Restricted Fluid Administration

EXPERIMENTAL

500ml iv fluid

Drug: Lactated Ringer 500ml

Interventions

Lactated Ringer 500ml DRUG

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

Restricted Fluid Administration

Lactated Ringer 1000ml DRUG

1000ml iv fluid given perioperatively in laparoscopic cholecystectomy

Liberal Fluid Administration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University Lahore / Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: March 23, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): July 28, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

PA (1)