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

Phase 4

Not yet recruiting

• Conditions: Paralytic Ileus
• Interventions: Drug: Dexamethasone; Drug: Dexmedetomidine

• Registration Number: NCT06752317
• Lead Sponsor: Assiut University

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.

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone group	Dexamethasone	patients will receive intrathecal dexamethasone 8 mg in 3 ml volume.
Dexmedetomidine group	Dexmedetomidine	patients will receive intrathecal dexmedetomidine 0.5 µg/kg in 3 ml volume.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative vomiting	24 hours	number of participants who had experienced vomiting on day 1.