Perioperative Dexamethasone on Postoperative Outcome in IBD

Jinling Hospital, China

Status and phase: Completed; Phase 2

Conditions: Postoperative Complications; Postoperative Ileus; Inflammatory Bowel Diseases; Dexamethasone

Treatments: Drug: Normal saline; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03456752

DEX-IBD

Details and patient eligibility

About

The objective of this RCT is to determine the efficacy of a single preoperative dose of Dexamethasone for accelerating the recovery and reducing the incidence of postoperative complications in adult patients undergoing intestinal resection for inflammatory bowel disease.

Full description

Patients undergoing surgery for IBD is associated with increased inflammatory response and incidence of prolonged ileus after surgery compared to other colorectal disease such as CRC. Previous studies have revealed that preoperative administration of glucocorticosteroids(GCs) decreased complications and length of postoperative length of hospital after major abdominal surgery as a likely consequence of attenuating the postsurgical inflammatory response. Also, a single dose of GCs did not increase complications in colorectal surgery. The aim of the study is to examine whether a single dose of dexamethasone prior to induction of anesthesia could promote the recovery of patients and reduce the incidence of prolonged ileus after surgery for IBD

Enrollment: 302 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients undergoing elective open and laparoscopic small and large bowel operations for IBD, including Crohn's Disease(CD) and Ulcerative Colitis (UC).
2. ASA I-III

Exclusion criteria

1. Diabetes or hyperglycemia
2. Active gastric ulceration confirmed endoscopically
3. Presence of ongoing infection (such as IAS) or infective chronic diseases
4. Currently receiving systemic therapy with glucocorticoids with prednisolone >=20mg for over 6 weeks within 30 days prior to surgery.
5. Emergent surgery
6. Acute angle glaucoma
7. Pregnancy
8. Under 18 years of age
9. Known adverse reaction to dexamethasone
10. Extensive adhesiolysis
11. Carcinogenesis of intestinal tract

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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302 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

Dexamethasone 8mg intravenously prior to anesthesia induction

Treatment:

Drug: Dexamethasone

Control

Placebo Comparator group

Description:

Normal Saline 1.6ml intravenously prior to anesthesia induction

Treatment:

Drug: Normal saline