Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05887258
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2023-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
Sponsor:
Unai Ortega Mera
Organization:
Study Overview
Official Title:
Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
Status:
COMPLETED
Status Verified Date:
2024-10
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:
OFA_GAL_21
Brief Summary:
The goal of this clinical trial is to compare opioid free anesthesia versus opioid anesthesia in patients undergo laparoscopic colorectal surgery. The main question it aims to answer is assess the efficacy of opioid-free anaesthesia respect to postoperative pain control in patients undergoing a laparoscopic colorectal surgery.
Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).
The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.
Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).
The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.
Detailed Description:
The objective of the study is to know the efficacy of OFA in laparoscopic colorectal surgery. The consumption of opiates will be evaluated according to the VAS scale, defining non-tolerable pain greater than 5. The number of rescues required, the time elapsed until the first rescue and the total consumption of opiates administered will be evaluated.
Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.
Other variables evaluated will be postoperative complications:
* Postoperative hypoxemia.
* Incidence of postoperative nausea and vomiting (PONV).
* Postoperative ileus.
* surgical complications.
* medical complications
Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.
Other variables evaluated will be postoperative complications:
* Postoperative hypoxemia.
* Incidence of postoperative nausea and vomiting (PONV).
* Postoperative ileus.
* surgical complications.
* medical complications
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: