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

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Paralytic Ileus

Treatments: Drug: Dexmedetomidine; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06752317

dexamethasone vsdexmedetomidin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Dexamethasone group

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Dexmedetomidine group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine