Perioperative Dexamethasone on Postoperative Outcome in IBD

Jinling Hospital, China302 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

302

Conditions

Inflammatory Bowel Diseases Dexamethasone Postoperative Ileus Postoperative Complications

Interventions

DexamethasoneDRUG

Dexamethasone 8mg intravenously prior to induction of anesthesia

Normal salineDRUG

Normal saline 1.6ml intravenously prior to induction of anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Prolonged ileus

Prolonged POI was defined as if two or more of the following five criteria are met on day 4 postoperatively: nausea or vomiting; inability to tolerate an oral diet over last 24 h; absence of flatus over last 24 h; abdominal distension; and radiologic confirmation.

Time frame: Day 30

Secondary Outcomes

PONV(Postoperative nausea and vomiting) and additional antiemetics given within 24hr after surgery

the incidence of any nausea, emetic episodes (retching or vomiting),or both (i.e., postoperative nausea and vomiting) during the first 24 postoperative hours.

Time frame: 24hr

Postoperative pain on POD 1, 3, and 5

Visual analog scale (VAS) for pain description (0-10 visual analogue pain scale)

Time frame: up to 1 week

Postoperative fagitue score on POD 1, 3, and 5

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale (Version 4). The FACIT-IT score is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued)

Time frame: up to 1 week

GI-2 recovery

time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2).

Time frame: Day 30

Blood WBC levels, preoperative and on postoperative 1,3 and 5

Time frame: Day 30

Blood neutrophil percentage, preoperative and on postoperative 1,3 and 5

Data from ClinicalTrials.gov

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