NCT07488078 Effect of Liberal and Restrictive IV Fluids on Recovery After Gallbladder Surgery
| NCT ID | NCT07488078 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | King Edward Medical University |
| Condition | Laparoscopic Cholecystectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-07-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 380 participants in total. It began in 2025-12-01 with a primary completion date of 2026-07-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07488078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Laparoscopic Cholecystectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07488078 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07488078 currently recruiting?
Yes, NCT07488078 is actively recruiting participants. Visit ClinicalTrials.gov or contact King Edward Medical University to inquire about joining.
Where is the NCT07488078 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07488078 clinical trial?
NCT07488078 is sponsored by King Edward Medical University. The trial plans to enroll 380 participants.