Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorrectal Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare opioid free anesthesia versus opioid anestheisa in patients undergo laparoscopic colorrectal 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.

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

Official Title
-----------------
Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorrectal Surgery

Conditions
-----------------
Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: Opioid free anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ( - ) Patients older than or equal to 18 years. (-) Patients scheduled for laparoscopic colorectal surgery. (-) Patients with physical status classification (ASA) I-III. (- ) Patients who have signed the informed consent of the clinical trial Exclusion Criteria: (-) Pregnant or lactating patients. (-)Patients with allergy to any of the drugs or excipients used in the study (-) Emergency laparoscopic colorectal surgery (-) Patients with AV block, intraventricular block, or sinus block (-) Adam-Stokes syndrome. (-) Patient on chronic beta-blocker treatment with HR < 50 bpm (-) Patient with ejection fraction < 40% known (-) Epilepsy. (-) Surgery converted to open surgery (-) Legally disabled patient (-) Patients with physical status classification (ASA) IV.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid free anesthesia (OFA)<br>This arm is composed of opiate-free anesthesia, for this we will use Dexmetomidine dexdor), lidocaine, magnesium sulfate, ketamine (ketolar), Dexketoprofen (Enantyum) , dexamethasone and acethominophen. | Drug: Opioid free anesthesia<br>* Administer a combination of drugs in substitution for morphine<br>* Other names: OFA;|
| Active Comparator: Opioid based Anesthesia (OA)<br>This arm of opiate-based anesthesia is composed of Remifentanil hidrochloride. Postoperative rescue analgesia will be morphine along with dexketoprofen, acethominophen, and dexamethasone. | Drug: Opioid free anesthesia<br>* Administer a combination of drugs in substitution for morphine<br>* Other names: OFA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control | milligrams of opioids required postoperatively during the first 3 of admission | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VNS score | Pain measured through the visual analogue scale (VAS) during the first 3 days of admission | 3 days | 
| morphine rescues | Number of opiate rescues required during the postoperative period | 7 days |