NCT05567094

The Effect of Perioperative DEXamethasone on Postoperative Complications After PANcreaticoduodenectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is evaluate the effect of dexamethasone on postoperative complications after pancreaticoduodenectomy.

Detailed description

This is a multicentric, prospective, randomized, double-blind, pragmatic, placebo-control study. Patients who are going to receive elective pancreaticoduodenectomy will be randomized to receive 0.2 mg/kg dexamethasone or saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia. The primary outcome is the Comprehensive Complication Index (CCI) score within 30 days after the operation, which will be compared between these two groups .

Conditions

• Pancreaticoduodenectomy

Interventions

Type	Name	Description
DRUG	Dexamethasone	Patients will receive 0.2 mg/kg dexamethasone, administered as an intravenous bolus within 5 minutes after induction of anesthesia
DRUG	Saline placebo	Patients will receive 2ml saline placebo, administered as an intravenous bolus within 5 minutes after induction of anesthesia

Timeline

• Start date: 2022-10-08
• Primary completion: 2023-09-14
• Completion: 2023-09-14
• First posted: 2022-10-05
• Last updated: 2023-09-18

Locations

1 site across 1 country: China