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

NCT06752317 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: dexamethasone vsdexmedetomidin
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Paralytic Ileus

Keywords

major abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative vomiting

  number of participants who had experienced vomiting on day 1.

  24 hours

Study Arms (2)

Dexamethasone group

EXPERIMENTAL

patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.

Drug: Dexamethasone

Dexmedetomidine group

EXPERIMENTAL

patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.

Drug: Dexmedetomidine

Interventions

Dexamethasone DRUG

patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.

Dexamethasone group

Dexmedetomidine DRUG

patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Interventions

Dexamethasone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Abdelrahman Mohamed Hamed, resident doctor

CONTACT

+201149919109; AbdElrahman.16266086@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12