Laparoscopic CholecystectomyPhase 1NCT07488078
Effect of Liberal and Restrictive IV Fluids on Recovery After Gallbladder Surgery
A Phase 1 study testing Lactated Ringer 500ml and Lactated Ringer 1000ml in people with Laparoscopic Cholecystectomy, run by King Edward Medical University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Lactated Ringer 500ml and Lactated Ringer 1000ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to 28 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients undergoing elective cholecystectomy
- Age : 18-60 years
- All genders
- ASA class 1 and 2
Who cannot join
- History of previous laparotomy
- Perforated gall bladder
- Duration of surgery more than 3 hours
- More than 100ml intra operative blood loss
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
King Edward Medical University Lahore / Mayo Hospital Lahore
Lahore, Punjab Province, 54000
Ahmad Uzair Qureshi, FCPS, +923144001410, ahmaduzairq@gmail.com
About this study
Official title: Effect of Liberal Versus Restrictive Intravenous Fluid Administration on Postoperative Homeostasis in Patients Undergoing Laparoscopic Cholecystectomy
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:
Read more
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
- Being tested
- Lactated Ringer 500ml, Lactated Ringer 1000ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer 500mlDrug
500ml ringer lactate perioperatively given in laparoscopic cholecystectomy patients as compared to traditional 1000ml fluid
Lactated Ringer 1000mlDrug
1000ml iv fluid given perioperatively in laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Liberal Fluid Administration | Active comparator | 1000ml iv fluid Receives: Drug: Lactated Ringer 1000ml |
| Restricted Fluid Administration | Experimental | 500ml iv fluid Receives: Drug: Lactated Ringer 500ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Systolic Blood Pressure
Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively
Measured: Day 1
Secondary outcomes (3)
Mean Pulse Rate Per Minute
Mean pulse rate per minute at pre operative, 3,6,12 and 24 hours post operatively
Measured: Day 1
Mean Diastolic Blood Pressure
Mean diastolic blood pressure at pre operative, 3,6,12 and 24 hours post operatively
Measured: Day 1
Mean Pulse Pressure
Mean pulse pressure at pre operative, 3,6,12 and 24 hours post operatively
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Dec 2025
- Primary completion28 Jul 2026 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488078
- Sponsor's protocol ID
- 335/RC/KEMU
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liberal Versus Restrictive Intravenous Fluid Administration on Postoperative Homeostasis in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07488078
- Acronym / sponsor ID
- 335/RC/KEMU
- Conditions
- Laparoscopic Cholecystectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal Fluid Administration | Active comparator | Drug: Lactated Ringer 1000ml1000ml iv fluid |
| Restricted Fluid Administration | Experimental | Drug: Lactated Ringer 500ml500ml iv fluid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients undergoing elective cholecystectomy
- Age : 18-60 years
- All genders
- ASA class 1 and 2
Key exclusion criteria (4 listed)
- History of previous laparotomy
- Perforated gall bladder
- Duration of surgery more than 3 hours
- More than 100ml intra operative blood loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated Ringer 500ml500ml ringer lactate perioperatively given in laparoscopic cholecystectomy patients as compared to traditional 1000ml fluid | Drug | Restricted Fluid Administration |
| Lactated Ringer 1000ml1000ml iv fluid given perioperatively in laparoscopic cholecystectomy | Drug | Liberal Fluid Administration |
Primary outcome
Mean Systolic Blood Pressure
Time frame: Day 1
Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively
3 secondary outcomes
Mean Pulse Rate Per Minute
Time frame: Day 1
Mean Diastolic Blood Pressure
Time frame: Day 1
Mean Pulse Pressure
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
King Edward Medical University Lahore / Mayo Hospital Lahore
Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactated Ringer 500ml and Lactated Ringer 1000ml in people with Laparoscopic Cholecystectomy, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Systolic Blood Pressure (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.