A Phase 1/2 interventional study of 0.9%sodium chloride and Dexamethasone in Postoperative Ileus, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by Assiut University · Phase 1/2, Interventional, and Prevention
Postoperative ileus is a perplexing problem for clinical surgeons. It occurs not only after abdominal surgery but also after any surgery that requires general anesthesia. Postoperative ileus is defined as the dysfunction of gastrointestinal motility after surgery, characterized by a decrease in, or stagnation of, intestinal peristalsis.
Common clinical manifestations include abdominal pain, abdominal distention, nausea, vomiting, delayed flatus, delayed defecation, and inability to consume orally. Postoperative ileus is an uncomfortable experience, enhances the possibility of postoperative complications, prolongs hospital stay, and increases the economic burden. Postoperative gastrointestinal function recovery is of great concern. There is currently an urgent need to improve postoperative recovery of gastrointestinal function. The mechanism of Postoperative ileus varies, including autonomic regulation, inflammatory response, gastrointestinal hormones, and postoperative use of opioid drugs. Surgical gut damage destroys the intestinal barrier, stimulates the sympathetic and parasympathetic nervous systems, and enhances the release of inflammatory factors. These factors precipitate the occurrence of Postoperative ileus. The current use of laparoscopic techniques can reduce incision size and surgical trauma, enabling careful manipulation.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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Contraindication
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Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
Drug: 0.9%sodium chloride
Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.
Drug: Dexamethasone
Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.
the time to first passage of flatus and or stool
the time to first passage of flatus and or stool through the first 24 hours and the time of return of intestinal sounds,
Time frame: 24 hours postoperative
Plan to share: Undecided
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Studies of the drug tested here: Dexamethasone