Health TrialsbyHealthPanel

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

ConditionLaparoscopic Cholecystectomy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing Edward Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing elective cholecystectomy

Age : 18-60 years

All genders

ASA class 1 and 2

Disqualifiers

History of previous laparotomy

Perforated gall bladder

Duration of surgery more than 3 hours

More than 100ml intra operative blood loss

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lactated Ringer 500ml

    Drug

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

  • Lactated Ringer 1000ml

    Drug

    1000ml iv fluid given perioperatively in laparoscopic cholecystectomy

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Liberal Fluid AdministrationActive comparator 1 intervention
Group B: Restricted Fluid AdministrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Systolic Blood Pressure

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

Time frame
Day 1

Secondary outcomes

1

Mean Pulse Rate Per Minute

Mean pulse rate per minute at pre operative, 3,6,12 and 24 hours post operatively

Time frame
Day 1
2

Mean Diastolic Blood Pressure

Mean diastolic blood pressure at pre operative, 3,6,12 and 24 hours post operatively

Time frame
Day 1
3

Mean Pulse Pressure

Mean pulse pressure at pre operative, 3,6,12 and 24 hours post operatively

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Edward Medical University

Lead sponsor

Source ClinicalTrials.gov
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