Laparoscopic Gastric BypassPhase 4NCT03001843
Ketamine vs Hydromorphone
A Phase 4 study testing Ketamine, Narcotics and pain scale in people with Laparoscopic Gastric Bypass and Obesity, run by University of Florida at 1 site in United States.
Trial summary
This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Gastric Bypass, Obesity, Pain, Postoperative
- What is being tested?
- Ketamine, Narcotics and pain scale
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 21 Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age
Who cannot join
- Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?
This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.
Read the detailed description
The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.
The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.
- Conditions
- Laparoscopic Gastric Bypass, Obesity, Pain, Postoperative
- Being tested
- Ketamine, Narcotics, pain scale
- Medical subject headings
- Obesity, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Anesthesia of only Ketamine
NarcoticsDrug
The narcotic group will receive no ketamine but rather a more standard anesthetic
pain scaleBehavioural
0-10 pain scale. 0 = no pain and 10 = worst pain
| Study group | Role | What they receive |
|---|---|---|
| Non-Ketamine | Active comparator | This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Receives: Drug: Narcotics; Behavioral: pain scale |
| Ketamine | Active comparator | This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Receives: Drug: Ketamine; Behavioral: pain scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measured Based on Pain Medication Used on a Scale of 0-10
Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale
Measured: 48 hours
Secondary outcomes (1)
Length of Stay (Hours)
Length of stay compared between the 2 groups in hours.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start22 Feb 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic Gastric BypassStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David M Smyth, MSN, Principal investigator, Shands Hospital at the University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001843
- Sponsor's protocol ID
- IRB201500836 -A
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2016
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?
- ClinicalTrials.gov ID
- NCT03001843
- Acronym / sponsor ID
- IRB201500836 -A
- Conditions
- Laparoscopic Gastric Bypass, Obesity, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.
Detailed description
The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.
The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Ketamine | Active comparator | Drug: Narcotics, Behavioral: pain scaleThis group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. |
| Ketamine | Active comparator | Drug: Ketamine, Behavioral: pain scaleThis group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age
Key exclusion criteria (1 listed)
- Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
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 |
|---|---|---|
| KetamineAlso: KetalarAnesthesia of only Ketamine | Drug | Ketamine |
| NarcoticsThe narcotic group will receive no ketamine but rather a more standard anesthetic | Drug | Non-Ketamine |
| pain scale0-10 pain scale. 0 = no pain and 10 = worst pain | Behavioural | Ketamine, Non-Ketamine |
Primary outcome
Pain Measured Based on Pain Medication Used on a Scale of 0-10
Time frame: 48 hours
Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale
1 secondary outcome
Length of Stay (Hours)
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David M Smyth, MSN principal investigator
Shands Hospital at the University of Florida
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 Ketamine, Narcotics and pain scale in people with Laparoscopic Gastric Bypass and Obesity, run by University of Florida 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 1 inclusion and 1 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 9 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Measured Based on Pain Medication Used on a Scale of 0-10 (time frame: 48 hours). 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 9 Mar 2021.