Colorectal SurgeryPhase 3OFA_GAL_21NCT05887258
Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
A Phase 3 study testing Opioid free anesthesia and Opioid based Anesthesia in people with Colorectal Surgery, run by Unai Ortega Mera at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Opioid free anesthesia and Opioid based Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2022to 15 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ( - ) 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
Who cannot join
- (-) 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
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- (-) Patient with ejection fraction < 40% known
- (-) Epilepsy.
- (-) Surgery converted to open surgery
- (-) Legally disabled patient
- (-) Patients with physical status classification (ASA) IV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
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.
Read the 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
- Conditions
- Colorectal Surgery
- Being tested
- Opioid free anesthesia, Opioid based Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid free anesthesiaDrug
Also called OFA
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.
Opioid based AnesthesiaDrug
Also called Traditional anesthesia
administer anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anesthesia (OFA) | Experimental | This arm is administered by the anesthesiologist in charge of the operating room.
It is composed by Dexmedetomidine (Dexdor), Lidocaine, Magnesium Sulfate and ketamine (Ketolar). Receives: Drug: Opioid free anesthesia |
| Opioid based Anesthesia (OA) | Active comparator | This arm is administered by the anesthesiologist in charge of the operating room.
This arm is composed of Remifentanil hydrochloride and postoperative rescue analgesia will be morphine. Receives: Drug: Opioid based Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control
milligrams of opioids required postoperatively during the first 3 of admission
Measured: 3 days
Secondary outcomes (2)
VNS score
Pain measured through the visual analogue scale (VAS) during the first 3 days of admission
Measured: 3 days
morphine rescues
Number of opiate rescues required during the postoperative period
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start15 May 2022
- Primary completion15 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unai Ortega Mera
- Sponsor type
- University, hospital or other
- Collaborators
- Osakidetza
- Responsible party
- Sponsor-investigator, Unai Ortega Mera, Osakidetza
- Investigators
- Unai Ortega, MD, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887258
- Sponsor's protocol ID
- 2021-003245-38
- Acronym
- OFA_GAL_21
- Status last verified
- Oct 2024
- First submitted
- 16 Apr 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05887258
- Acronym / sponsor ID
- OFA_GAL_21 / 2021-003245-38
- Conditions
- Colorectal Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Unai Ortega MeraUniversity, hospital or other
- Collaborators
- Osakidetza
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid free anesthesia (OFA) | Experimental | Drug: Opioid free anesthesiaThis arm is administered by the anesthesiologist in charge of the operating room. It is composed by Dexmedetomidine (Dexdor), Lidocaine, Magnesium Sulfate and ketamine (Ketolar). |
| Opioid based Anesthesia (OA) | Active comparator | Drug: Opioid based AnesthesiaThis arm is administered by the anesthesiologist in charge of the operating room. This arm is composed of Remifentanil hydrochloride and postoperative rescue analgesia will be morphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ( - ) 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
Key exclusion criteria (11 listed)
- (-) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid free anesthesiaAlso: OFAIt 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. | Drug | Opioid free anesthesia (OFA) |
| Opioid based AnesthesiaAlso: Traditional anesthesiaadminister anesthesia based on opioids such as fentanyl and/or morphine to guarantee analgesia during the surgical intervention. | Drug | Opioid based Anesthesia (OA) |
Primary outcome
Pain control
Time frame: 3 days
milligrams of opioids required postoperatively during the first 3 of admission
2 secondary outcomes
VNS score
Time frame: 3 days
morphine rescues
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unai Ortega, MD principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Opioid free anesthesia and Opioid based Anesthesia in people with Colorectal Surgery, run by Unai Ortega Mera at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.