AnesthesiaNCT03124680
Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient
A study testing Opioid free and opioid group in people with Anesthesia, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis. For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Opioid free and opioid group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Apr 2017to 1 Jul 2017
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing a gastric by-pass surgery will be screened.
- Patients with an ASA physical status of I-II-III (BMI >30) will be included.
- Knowledge of either French, English or Dutch will be required in order to be enrolled in this study.
Who cannot join
- allergy or contraindications to one of the study drugs
- renal failure
- hepatic failure
- hyperthyroidism
- AV block 2 or 3
- severe bradycardia
Show all 11Show fewer
- left ventricular failure
- unstable blood pressure
- severe respiratory disease
- epilepsy
- psychiatric disturbance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient: How About Another Approach?
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.
For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known.
Read more
Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.
Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.
Non-opiate protocols implemented on the obese patient have been published. Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.
The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.
Read the detailed description
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.
For a long time, opioids have been covering the analgesia function. When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. These complications may lead to a prolonged hospital stay.
Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.
Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.
Authors have indeed published non-opiate protocols implemented on the obese patient.
Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.
The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.
- Conditions
- Anesthesia
- Being tested
- Opioid free, opioid group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid freeCombination product
Also called study group
Peroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate
opioid groupCombination product
Also called control group
Opioid anesthesia will follow the current standard approach of our hospital.
| Study group | Role | What they receive |
|---|---|---|
| opioid free group | Active comparator | Opioid free group using dexmedetomidine, ketamine, lidocaine, MgSO4 Receives: Combination Product: Opioid free |
| Opioid group | Placebo comparator | Opioid group using sufentanil, lidocaine, clonidine Receives: Combination Product: opioid group |
What is being measured
The primary outcome is the main question the study is designed to answer.
desaturation episode evaluation
The primary outcome of this study is to evaluate desaturation episodes during the first 24 h post-bariatric surgery in patients having received an opioid or an opioid free anaesthesia.
Desaturation is defined as a decrease of oxygen desaturation equal to or exceeding 4% of the baseline value. ODI (oxygen desaturation index), the total number of desaturation events divided by the total time of monitoring in hours, will be calculated to evaluate this outcome in both groups.
In case of desaturation lasting longer than 10 seconds, oxygen (via nasal canula) will be administered as per post-anaesthesia care unit protocol.
SP02 will be measured for 24 hours through non-invasive monitoring.
Measured: first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start20 Apr 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Saxena, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124680
- Sponsor's protocol ID
- OFA
- Status last verified
- Jul 2017
- First submitted
- 31 Mar 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anesthesia and Continuous Post-operative Pulse Oximetry Monitoring in the Obese Patient: How About Another Approach?
- ClinicalTrials.gov ID
- NCT03124680
- Acronym / sponsor ID
- OFA
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 24 Apr 2017 (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.
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.
For a long time, opioids have been covering the analgesia function. (1) When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known.
Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.
Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.
Non-opiate protocols implemented on the obese patient have been published. Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.
The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.
Detailed description
Anaesthesia has three major components, analgesia, muscle relaxation and hypnosis.
For a long time, opioids have been covering the analgesia function. When using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. Post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. These complications may lead to a prolonged hospital stay.
Opioid usage is an important risk factor of postoperative desaturation. Postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications.
Thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage.
Authors have indeed published non-opiate protocols implemented on the obese patient.
Non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist.
The main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid free group | Active comparator | Combination Product: Opioid freeOpioid free group using dexmedetomidine, ketamine, lidocaine, MgSO4 |
| Opioid group | Placebo comparator | Combination Product: opioid groupOpioid group using sufentanil, lidocaine, clonidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing a gastric by-pass surgery will be screened.
- Patients with an ASA physical status of I-II-III (BMI >30) will be included.
- Knowledge of either French, English or Dutch will be required in order to be enrolled in this study.
Key exclusion criteria (11 listed)
- allergy or contraindications to one of the study drugs
- renal failure
- hepatic failure
- hyperthyroidism
- AV block 2 or 3
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 freeAlso: study groupPeroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate | Combination product | opioid free group |
| opioid groupAlso: control groupOpioid anesthesia will follow the current standard approach of our hospital. | Combination product | Opioid group |
Primary outcome
desaturation episode evaluation
Time frame: first 24 hours postoperative
The primary outcome of this study is to evaluate desaturation episodes during the first 24 h post-bariatric surgery in patients having received an opioid or an opioid free anaesthesia. Desaturation is defined as a decrease of oxygen desaturation equal to or exceeding 4% of the baseline value. ODI (oxygen desaturation index), the total number of desaturation events divided by the total time of monitoring in hours, will be calculated to evaluate this outcome in both groups. In case of desaturation lasting longer than 10 seconds, oxygen (via nasal canula) will be administered as per post-anaesthesia care unit protocol. SP02 will be measured for 24 hours through non-invasive monitoring.
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 19 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid free and opioid group in people with Anesthesia, run by Université Libre de Bruxelles at 1 site in Belgium.
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 3 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 19 Jul 2017. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
desaturation episode evaluation (time frame: first 24 hours postoperative). 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 19 Jul 2017.