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NCT Number: NCT06752317

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Dexmedetomidine

Drug

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

Primary outcomes

  1. Incidence of postoperative vomiting

    Time frame: 24 hours

    number of participants who had experienced vomiting on day 1.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Mohamed Hamed, resident doctor

CONTACT

[email protected]

+201149919109

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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