Viewing Study NCT02882035


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Study NCT ID: NCT02882035
Status: COMPLETED
Last Update Posted: 2016-08-29
First Post: 2016-08-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Opioid Free Anesthesia: What About Patient Comfort?
Sponsor: Université Libre de Bruxelles
Organization:

Study Overview

Official Title: Opioid Free Anesthesia: What About Patient Comfort?
Status: COMPLETED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.
Detailed Description: Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.

The purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.

The hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: