Postoperative Quality of RecoveryPhase 4NCT04144153
Opioid Free Anesthesia and Bariatric Surgery
A Phase 4 study testing Opioid Free Total Intravenous Anesthesia and Total Intravenous anesthesia with opioid in people with Postoperative Quality of Recovery, run by Northwell Health at 1 site in United States.
Trial summary
The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Quality of Recovery
- What is being tested?
- Opioid Free Total Intravenous Anesthesia and Total Intravenous anesthesia with opioid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 1 Sep 2023
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Non-pregnant
- Undergoing laparoscopic bariatric surgery for weight loss.
Who cannot join
- Unable to obtain informed consent or consent withdrawn.
- Patients who are pregnant or nursing.
- ASA IV-V
- Alcohol or narcotic misuse or dependence in the last 2 years.
- Preoperative daily opioid use for one year for pain management.
- Egg or soy product allergy
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- Active liver disease
- Patients with left ventricular assist devices
- Abnormal renal function
- Any contraindication to any opioid or non-opioid pain analgesics
- Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: Opioid Free Total Intravenous Anesthesia Within an Enhanced Recovery After Surgery Pathway for Bariatric Surgery: A Randomized Controlled Clinical Trial
The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.
- Conditions
- Postoperative Quality of Recovery
- Being tested
- Opioid Free Total Intravenous Anesthesia, Total Intravenous anesthesia with opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free Total Intravenous AnesthesiaCombination product
Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
Total Intravenous anesthesia with opioidCombination product
Total Intravenous anesthesia with opioid
| Study group | Role | What they receive |
|---|---|---|
| Opioid Free Anesthesia Group | Experimental | Not described Receives: Combination Product: Opioid Free Total Intravenous Anesthesia |
| Opioid Anesthesia Group | Active comparator | Not described Receives: Combination Product: Total Intravenous anesthesia with opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: Up to two postoperative weeks
Secondary outcomes (3)
Pain Intensities
Postoperative pain intensities using a 0 to 10 numerical rating scale (NRS) with higher scores indicative of higher pain intensities.
Measured: Up to postoperative day one
Opioid Consumption
Total postoperative opioid consumption
Measured: Up to postoperative day one
Time to Aldrete Score of 9
Time to post-anesthesia care unit discharge readiness
Measured: Up to postoperative day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start9 Aug 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Aronsohn, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144153
- Sponsor's protocol ID
- 19-0728
- Status last verified
- Sep 2024
- First submitted
- 28 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Total Intravenous Anesthesia Within an Enhanced Recovery After Surgery Pathway for Bariatric Surgery: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04144153
- Acronym / sponsor ID
- 19-0728
- Conditions
- Postoperative Quality of Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 Oct 2019 (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 morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Free Anesthesia Group | Experimental | Combination Product: Opioid Free Total Intravenous Anesthesia |
| Opioid Anesthesia Group | Active comparator | Combination Product: Total Intravenous anesthesia with opioid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Non-pregnant
- Undergoing laparoscopic bariatric surgery for weight loss.
Key exclusion criteria (11 listed)
- Unable to obtain informed consent or consent withdrawn.
- Patients who are pregnant or nursing.
- ASA IV-V
- Alcohol or narcotic misuse or dependence in the last 2 years.
- Preoperative daily opioid use for one year for pain management.
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 Total Intravenous AnesthesiaTotal intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride | Combination product | Opioid Free Anesthesia Group |
| Total Intravenous anesthesia with opioidTotal Intravenous anesthesia with opioid | Combination product | Opioid Anesthesia Group |
Primary outcome
Quality of Recovery
Time frame: Up to two postoperative weeks
Quality of Recovery (QoR-15), a patient-reported outcome questionnaire that assesses the quality of functional recovery after surgery and anesthesia with a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
3 secondary outcomes
Pain Intensities
Time frame: Up to postoperative day one
Opioid Consumption
Time frame: Up to postoperative day one
Time to Aldrete Score of 9
Time frame: Up to postoperative day one
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 Sep 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.
Judith Aronsohn, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opioid Free Total Intravenous Anesthesia and Total Intravenous anesthesia with opioid in people with Postoperative Quality of Recovery, run by Northwell Health at 1 site in United States.
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 Sep 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Quality of Recovery (time frame: Up to two postoperative weeks). 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 Sep 2024.