Colorectal Surgery
Conditions
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.
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
Interventions
DRUGOpioid free anesthesia
It administers a combination of drugs to replace the opioid derivatives. Among them, we will use lidocaine, ketamine, dexmetomidine, and magnesium sulfate in continuous infusion adjusted to the patient's weight during surgery.
administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.
Sponsors
Osakidetza
Unai Ortega Mera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain control | 3 days | milligrams of opioids required postoperatively during the first 3 of admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VNS score | 3 days | Pain measured through the visual analogue scale (VAS) during the first 3 days of admission |
| morphine rescues | 7 days | Number of opiate rescues required during the postoperative period |
Other
| Measure | Time frame | Description |
|---|---|---|
| intraoperative Security | 1 day | Presentation of complications during the surgical intervention defined as a situation that requires immediate action by the anesthetist and lasts more than 30 minutes, the interruption of the operation and/or conversion to open surgery. |
| postoperative security | 3 day | Operative hypoxemia defined as oxygen saturation by pulseoximetry less than 90% Incidence of Postoperative Nausea and Vomiting (PONV) during de first 3 days Postoperative ileus defined as the absence of bowel movements during the first 3 days |
Countries
Spain
Outcome results
None listed