Clinical trial NCT05887258: Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
Official title: Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Surgery
Lead sponsor: Osakidetza
Sponsor class: OTHER
Collaborators: name: Osakidetza
First posted: 2023-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Pain control
timeFrame: 3 days
Secondary outcomes:
measure: VNS score
timeFrame: 3 days
measure: morphine rescues
timeFrame: 7 days
Other outcomes:
measure: intraoperative Security
timeFrame: 1 day
measure: postoperative security
timeFrame: 3 day
Locations:
city: Galdakao
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
Study officials:
affiliation: Osakidetza
name: Unai Ortega, MD
role: PRINCIPAL_INVESTIGATOR
References: