A Phase 2/3 interventional study of Baclofen Tablets in Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy and Morbid Obesity, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by Tanta University · Phase 2/3, Interventional, and Prevention
This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
. A total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into four groups by closed envelop method
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
include 50 patients scheduled for sleeve gastrectomy
which include 50 patients scheduled for sleeve gastrectomy
Drug: Baclofen Tablets
10 mg oral baclofen 1 h before anesthesia
Also known as: baclofen
The primary outcome of this study will be the complete response
Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy.
Time frame: The first 48 hours after surgery.
Change in serum level of vasopressin
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time frame: The first 48 hours after surgery.
Change in serum level of substance P
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time frame: The first 48 hours after surgery.
Change in serum level of dopamine
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time frame: The first 48 hours after surgery.
Change in serum level of serotonin
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time frame: The first 48 hours after surgery.
Change in serum level of tachykinin 1
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Time frame: The first 48 hours after surgery.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Tanta University