Effect of Preoperative Intrathecal Dexamethasone Versus Dexmedetomidine on Paralytic Ileus After Major Abdominal Surgery
NCT ID: NCT06752317
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2025-01-01
2026-03-01
Brief Summary
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Dexamethasone \& Dexmedetomidine have been reported to attenuate the incidence of paralytic ileus after abdominal surgeries.
Previous study has shown that a single dose of DM before induction of anesthesia may be beneficial to reduce ileus for IBD by alleviating the postoperative systemic inflammatory response.
Perioperative dexmedetomidine in major abdominal surgeries significantly decreased the time to flatus, defecation, and resuming normal diet, shortened length of stay, and improved haemodynamic stability.
The aim of this study is to compare the effect of preoperative intrathecal dexamethasone versus dexmedetomidine on paralytic ileus after major abdominal surgery.
Detailed Description
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Dexamethasone \& Dexmedetomidine have been reported to attenuate the incidence of paralytic ileus after abdominal surgeries.
Previous study has shown that a single dose of DM before induction of anesthesia may be beneficial to reduce ileus for IBD by alleviating the postoperative systemic inflammatory response.
Perioperative dexmedetomidine in major abdominal surgeries significantly decreased the time to flatus, defecation, and resuming normal diet, shortened length of stay, and improved haemodynamic stability.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexamethasone group
patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.
Dexamethasone
patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.
Dexmedetomidine group
patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.
Dexmedetomidine
patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.
Interventions
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Dexamethasone
patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.
Dexmedetomidine
patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.
Eligibility Criteria
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Inclusion Criteria
* Sex: both males and females.
* ASA physical status: I and II.
* Operation: Open major abdominal surgery.
* The surgery has to involve gastrointestinal resection and/or anastomosis.
Exclusion Criteria
* Allergy to dexamethasone or dexmedetomidine
* Electrolyte disturbance
* Patient who receive any drugs known to influence gastrointestinal motility.
* Mental disorders or inability to cooperate
* Morbid obesity (BMI \> 40), pregnancy, lactation
* Diabetes
* After neoadjuvant chemotherapy.
* History of use of any steroids within the last 3 months
* Previous abdominal surgery, herniorrhaphy or unplanned secondary surgery
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Abdelrahman Mohamed Hamed
resident doctor at Assiut University hospital
Central Contacts
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Abdelrahman Mohamed Hamed, resident doctor
Role: CONTACT
Phone: +201149919109
Email: [email protected]
References
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Abernethy EK, Aly EH. Postoperative Ileus after Minimally Invasive Colorectal Surgery: A Summary of Current Strategies for Prevention and Management. Dig Surg. 2024;41(2):79-91. doi: 10.1159/000537805. Epub 2024 Feb 15.
Chen Y, Dong C, Lian G, Li D, Yin Y, Yu W, Du C, Liu C, Li L, Tian F, Jing C. Dexamethasone on postoperative gastrointestinal motility: A placebo-controlled, double-blinded, randomized controlled trial. J Gastroenterol Hepatol. 2020 Sep;35(9):1549-1554. doi: 10.1111/jgh.15020. Epub 2020 Mar 5.
Zhang T, Xu Y, Yao Y, Jin L, Liu H, Zhou Y, Gu L, Ji Q, Zhu W, Gong J. Randomized Controlled Trial: Perioperative Dexamethasone Reduces Excessive Postoperative Inflammatory Response and Ileus After Surgery for Inflammatory Bowel Disease. Inflamm Bowel Dis. 2021 Oct 20;27(11):1756-1765. doi: 10.1093/ibd/izab065.
Lee MJ, Vaughan-Shaw P, Vimalachandran D; ACPGBI GI Recovery Group. A systematic review and meta-analysis of baseline risk factors for the development of postoperative ileus in patients undergoing gastrointestinal surgery. Ann R Coll Surg Engl. 2020 Mar;102(3):194-203. doi: 10.1308/rcsann.2019.0158. Epub 2019 Dec 20.
Other Identifiers
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dexamethasone vsdexmedetomidin
Identifier Type: -
Identifier Source: org_study_id