Randomized clinical trial to compare the efficacy of opioid-free versus traditional balanced anesthesia in laparoscopic colorectal surgery

Randomized clinical trial to compare the efficacy of opioid-free versus traditional balanced anesthesia in laparoscopic colorectal surgery - OFA_GAL_21

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003245-38-ES

Enrollment

164

Registered

2021-11-10

Start date

2022-03-08

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

laparoscopic colorectal surgery

Interventions

Trade Name: Propofol Hospira Product Name: Propofol Pharmaceutical Form: Emulsion for injection/infusion Trade Name: Propofol Hospira Product Name: Propofol Pharmaceutical Form: Emulsion for injectio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients aged 18 years or older. ? Patients with scheduled laparoscopic colorectal surgery. ? Patients with physical status classification (ASA) I-III. ? Patients who have signed the informed consent for the clinical trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 164 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Pregnant or lactating patients. ? Patients with an allergy to any of the drugs or excipients used in the study. ? Emergency laparoscopic colorectal surgery. ? Patients with physical status classification (ASA) IV. ? Patients with AV block, intraventricular or sinus block. ? Adam-Stokes syndrome. ? Patient on chronic beta-blockers treatment with HR <50 bpm. ? Patient with known ejection fraction <40%. ? Epilepsy. ? Chronic opioid user. ? Surgery converted to open surgery. ? Legally disabled patient.

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate the non-inferiority of opioid-free versus traditional opioid-based balanced anesthesia with respect to postoperative pain control in patients undergoing laparoscopic colorectal surgery;Secondary Objective: 1.- To evaluate the safety of the use of opioid-free anesthesia in laparoscopic colorectal surgery. 2.- To evaluate a reduction in postoperative hypoxemia of laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia. 3.- To evaluate a reduction in postoperative nausea and vomiting after laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia. 4.- To evaluate a reduction in postoperative ileus after laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia. 5.- Reduce the number of days of hospital stay after laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia.;Primary end point(s): The main variable is the efficacy of opioid-free anesthesia compared to traditional balanced anesthesia in the control of postoperative pain.;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Main Objective: Demonstrate the non-inferiority of opioid-free versus traditional opioid-based balanced anesthesia with respect to postoperative pain control in patients undergoing laparoscopic colorectal surgery;Secondary Objective: 1.- To evaluate the safety of the use of opioid-free anesthesia in laparoscopic colorectal surgery. 2.- To evaluate a reduction in postoperative hypoxemia of laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia. 3.- To evaluate a reduction in postoperative nausea and vomiting after laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia. 4.- To evaluate a reduction in postoperative ileus after laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia. 5.- Reduce the number of days of hospital stay after laparoscopic colorectal surgery in patients who received opioid-free anesthesia compared to traditional balanced anesthesia.;Primary end point(s): The main variable is the efficacy of opioid-free anesthesia compared to traditional balanced anesthesia in the control of postoperative pain.;Timepoint(s) of evaluation of this end point: 36 months

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Secondary

Measure	Time frame
Secondary end point(s): ? Safety variables: Intraoperative complications: They are defined as those complications maintained for more than 30 minutes that require immediate action by the anesthesiologist, the interruption of the procedure and / or conversion to open surgery. ? Safety variables: Postoperative complications: o Postoperative hypoxemia. o Incidence of postoperative Nausea and Vomiting (PONV). o Postoperative ileus. o Other surgical complications. o Other medical complications. ? Days of hospital stay. ? Sociodemographic data: sex, year of birth. ? Hemodynamic variables during surgery and admission: HR, TAS, TAD, TAM. ? Clinical data related to the surgical intervention. ? Clinical evaluation data in the immediate postoperative period in the Resuscitation Unit. ? Clinical evaluation data in the postoperative period during admission to the Hospitalization Ward (days +0, +1, +2 and +3). ? Clinical assessment data 15 days after hospital discharge.;Timepoint(s) of evaluation of this end point: 36 months	—

Measure

Time frame

Secondary end point(s): ? Safety variables: Intraoperative complications: They are defined as those complications maintained for more than 30 minutes that require immediate action by the anesthesiologist, the interruption of the procedure and / or conversion to open surgery. ? Safety variables: Postoperative complications: o Postoperative hypoxemia. o Incidence of postoperative Nausea and Vomiting (PONV). o Postoperative ileus. o Other surgical complications. o Other medical complications. ? Days of hospital stay. ? Sociodemographic data: sex, year of birth. ? Hemodynamic variables during surgery and admission: HR, TAS, TAD, TAM. ? Clinical data related to the surgical intervention. ? Clinical evaluation data in the immediate postoperative period in the Resuscitation Unit. ? Clinical evaluation data in the postoperative period during admission to the Hospitalization Ward (days +0, +1, +2 and +3). ? Clinical assessment data 15 days after hospital discharge.;Timepoint(s) of evaluation of this end point: 36 months

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Countries

Spain

Contacts

Public ContactNURIA ZAZO

BIOCRUCES BIZKAIA

nuria.zazoperez@osakidetza.eus0034946182630

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026