NCT00733434

The Use of Prostaglandin E1 in Head and Neck Microsurgery

Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.

Detailed description

Despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. Postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 in every patient after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.

Conditions

• Microsurgery
• Head and Neck
• Prostaglandin E1
• Thrombosis
• Complications

Interventions

Type	Name	Description
DRUG	Prostaglandin E1	PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
OTHER	Saline	500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-07-01
• Completion: 2010-07-01
• First posted: 2008-08-13
• Last updated: 2009-10-27

Locations

1 site across 1 country: Taiwan