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Not yet recruiting NCT06752317

Effect of Preoperative Intrathecal Dexamethasone Versus Dexmedetomidine on Paralytic Ileus After Major Abdominal Surgery

Phase IV Interventional Paralytic Ileus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Dexmedetomidine.
Who it may be relevant to
Registry conditions: Paralytic Ileus. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Postoperative Ileus (POI) is considered as intolerance of oral intake due to disruption of the normal coordinated propulsive motor activity of the gastrointestinal (GI) tract following abdominal or non-abdominal surgery. 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

Postoperative Ileus (POI) is considered as intolerance of oral intake due to disruption of the normal coordinated propulsive motor activity of the gastrointestinal (GI) tract following abdominal or non-abdominal surgery.

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.

Interventions

  • Drug Dexamethasone
    patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.
  • Drug Dexmedetomidine
    patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.

Primary outcome measures

  • Incidence of postoperative vomiting [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • • Age: 18-60 years.
  • 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

  • • History of abnormal bowl habit or bowel obstruction
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 38359801
  • 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. PMID 32103514
  • 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. PMID 33749741
  • 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. PMID 31858809

Identifiers

NCT: NCT06752317 · dexamethasone vsdexmedetomidin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗