NCT05804591 Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).
| NCT ID | NCT05804591 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Warsaw |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-04-24 |
| Primary Completion | 2025-04-01 |
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 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2023-04-24 with a primary completion date of 2025-04-01.
⚠ 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 aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability. The participants will be divided into 2 groups: with or without preemptive pregabalin administration.
Eligibility Criteria
Inclusion Criteria: * Sleeve gastrectomy in patients with BMI \> 40 or \>35 with comorbidities * Written informed consent Exclusion Criteria: * Patient's refusal * Known allergies to study medication * Inability to comprehend or participate In pain scoring scale * Inability to use intravenous patient controlled analgesia * Changes of operation extent during procedure * Revisional operations * End stage organ failure
Contact & Investigator
Piotr Mieszczański, MD
PRINCIPAL INVESTIGATOR
Medical University of Warsaw
Frequently Asked Questions
Who can join the NCT05804591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. 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 NCT05804591 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05804591 currently recruiting?
Yes, NCT05804591 is actively recruiting participants. Contact the research team at piotr.mieszczanski@gmail.com for enrollment information.
Where is the NCT05804591 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT05804591 clinical trial?
NCT05804591 is sponsored by Medical University of Warsaw. The principal investigator is Piotr Mieszczański, MD at Medical University of Warsaw. The trial plans to enroll 90 participants.
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