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Not yet recruitingNCT06752317Updated Dec 30, 2024

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

A Phase 4 interventional study of Dexamethasone and Dexmedetomidine in Paralytic Ileus, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-30.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Paralytic Ileus

Keywords

  • major abdominal surgery
03

In context

Intestinal Pseudo-Obstruction

26 studies on the registry are indexed under Intestinal Pseudo-Obstruction; 6 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 18 interventional studies indexed under Intestinal Pseudo-Obstruction.

Browse Intestinal Pseudo-Obstruction studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Age: 18-60 years.

      • Sex: both males and females.
      • : I and II.
      • Operation: Open major abdominal surgery.
      • The surgery has to involve gastrointestinal resection and/or anastomosis.

Exclusion criteria

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 ( > 40), pregnancy, lactation
      • Diabetes
      • After chemotherapy.
      • History of use of any within the last 3 months
      • Previous abdominal surgery, herniorrhaphy or unplanned secondary surgery
Terms in these criteria, in plain language(4)

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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

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.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Dexamethasone group

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

    Drug: Dexamethasone

  • Experimental
    Dexmedetomidine group

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

    Drug: Dexmedetomidine

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. Incidence of postoperative vomiting

    number of participants who had experienced vomiting on day 1.

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 31858809 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06752317
Lead sponsor
Assiut University
Responsible party
Abdelrahman Mohamed Hamed (resident doctor at Assiut University hospital, Assiut University) — Principal investigator
First posted
Dec 30, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Dec 30, 2024

Study contacts

Abdelrahman Mohamed Hamed, resident doctor
Contact
AbdElrahman.16266086@med.aun.edu.eg
+201149919109

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Dexamethasone · Dexmedetomidine

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