ERAS in Video-assisted Mediastinal Surgery

Enhanced Recovery After Surgery Clinical Trial

Official title:

The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03271606
• Other study ID #: zs2017822
• Status: Recruiting
• Phase: Phase 1
• First received: August 23, 2017
• Last updated: September 1, 2017
• Start date: August 23, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: September 2017
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.

Description:

Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients elective mediastinal surgery;

• BMI 18-30 kg/m2.

Exclusion Criteria:

• Patient refuse;

• ASA=3;

• Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery

Intervention

Combination Product:
• ERAS
The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery
• Traditional measures
The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15-item quality of recovery scale (QoR-15)	This scale mainly reflects the patient's status	At preoperative vist
Primary	15-item quality of recovery scale (QoR-15)	This scale mainly reflects the patient's status	At 24 hours after surgery