Laparoscopic Gastric Bypass SurgeryPhase 2NCT03448068
Perioperative Ketamine for Pain With Gastric Bypass
A Phase 2 study testing Ketamine and Standard therapy in people with Laparoscopic Gastric Bypass Surgery and Ketamine, run by Mayo Clinic at 1 site in United States.
Trial summary
Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Gastric Bypass Surgery, Ketamine
- What is being tested?
- Ketamine and Standard therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 9 Jan 2020
- Phase
- Phase 2
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona
- BMI is ≥ 35 kg/m2
- Consent is able to be obtained as per Mayo Clinic policy
Who cannot join
- Intolerance to ketamine
- History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features
- Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)
- Presence of acute elevation of intracranial or intraocular pressure
- Presence of seizure disorder
- History of substance abuse or addiction
Show all 10Show fewer
- Creatinine greater than 1.5 mg/dL
- End-stage liver disease
- Pregnancy
- Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass
Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea.
Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients.
This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.
- Conditions
- Laparoscopic Gastric Bypass Surgery, Ketamine
- Being tested
- Ketamine, Standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine 0.3 mg/kg (IBW) bolus with induction. Ketamine infusion 0.2mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.
Ketamine infusion not titrated.
Standard therapyDrug
Pre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses.
Other standard surgical post-op care
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Therapy | Experimental | 1. Ketamine 0.3 mg/kg (IBW) bolus with induction.
2. Ketamine infusion 0.2 mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.
3. Ketamine infusion will not be titrated.
4. Remaining care will be identical to standard therapy group. Receives: Drug: Ketamine |
| Standard Therapy | Active comparator | 1. Calculation ideal body weight (IBW)
2. Pre-op dexamethasone
3. Pre-op midazolam at discretion of anesthesiologist
4. Anesthesia Induction - Propofol and fentanyl, anesthesiologist discretion. Neuromuscular block with succinylcholine and/or rocuronium at discretion of anesthesiologist. Orotracheal intubation.
5. Anesthesia Maintenance - Sevoflurane/rocuronium. Addl. doses of fentanyl, discretion of anesthesiologist.
6. Emergence from anesthesia - Acetaminophen, Ketorolac and Ondansetron unless contraindicated. Sugammadex depending on twitch response per drug manufacturer recommended protocol.
7. Post-Op Analgesia - Hydromorphone, acetaminophen and ketorolac
8. Other post-op care as per usual surgical routine Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cumulative Perioperative Opioid Dose
Measured in oral morphine equivalents
Measured: approximately 48 hours after induction of anesthesia
Secondary outcomes (7)
Average Pain Score 0-12 Hours
Patient reported pain scores at 0-12 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.
Measured: approximately 0-12 hours post operatively
Average Pain Score 12-24 Hours
Patient reported pain scores at 12-24 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.
Measured: approximately 12-24 hours post operatively
Average Pain Score 24-48 Hours
Patient reported pain scores at 24-48 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.
Measured: approximately 24-48 hours post operatively
Post-Operative Nausea
Number of subject to experience post-operative nausea
Measured: 12 hours, 24 hours, and 48 hours
Length of Stay in Hospital
Length of hospital stay measured in hours
Measured: Arrival at hospital until discharge from hospital, approximately 2 days
Patient Satisfaction With Pain Control at Time of Hospital Discharge
Self-reported questionnaire at the time of discharge from the hospital rating satisfaction of pain treatment while in the hospital using a scale of 0= extremely dissatisfied, 10 = extremely satisfied.
Measured: approximately 1-2 days post-operatively
Patient Satisfaction With Pain Control at Postoperative Visit
Self-reported questionnaire at the time of first post-operative visit with the surgeon, rating the worst amount of pain since being discharged from the hospital using a scale of 0= no pain, 10 = worst pain possible.
Measured: approximately 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start16 Apr 2018
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
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 Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Gorlin, MD, Mayo Clinic
- Investigators
- Andrew W Gorlin, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448068
- Sponsor's protocol ID
- 17-000301
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2018
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT03448068
- Acronym / sponsor ID
- 17-000301
- Conditions
- Laparoscopic Gastric Bypass Surgery, Ketamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea.
Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients.
This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Therapy | Experimental | Drug: Ketamine1. Ketamine 0.3 mg/kg (IBW) bolus with induction. 2. Ketamine infusion 0.2 mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours. 3. Ketamine infusion will not be titrated. 4. Remaining care will be identical to standard therapy group. |
| Standard Therapy | Active comparator | Drug: Standard therapy1. Calculation ideal body weight (IBW) 2. Pre-op dexamethasone 3. Pre-op midazolam at discretion of anesthesiologist 4. Anesthesia Induction - Propofol and fentanyl, anesthesiologist discretion. Neuromuscular block with succinylcholine and/or rocuronium at discretion of anesthesiologist. Orotracheal intubation. 5. Anesthesia Maintenance - Sevoflurane/rocuronium. Addl. doses of fentanyl, discretion of anesthesiologist. 6. Emergence from anesthesia - Acetaminophen, Ketorolac and Ondansetron unless contraindicated. Sugammadex depending on twitch response per drug manufacturer recommended protocol. 7. Post-Op Analgesia - Hydromorphone, acetaminophen and ketorolac 8. Other post-op care as per usual surgical routine |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona
- BMI is ≥ 35 kg/m2
- Consent is able to be obtained as per Mayo Clinic policy
Key exclusion criteria (10 listed)
- Intolerance to ketamine
- History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features
- Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)
- Presence of acute elevation of intracranial or intraocular pressure
- Presence of seizure disorder
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 |
|---|---|---|
| KetamineKetamine 0.3 mg/kg (IBW) bolus with induction. Ketamine infusion 0.2mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours. Ketamine infusion not titrated. | Drug | Ketamine Therapy |
| Standard therapyPre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses. Other standard surgical post-op care | Drug | Standard Therapy |
Primary outcome
Total Cumulative Perioperative Opioid Dose
Time frame: approximately 48 hours after induction of anesthesia
Measured in oral morphine equivalents
7 secondary outcomes
Average Pain Score 0-12 Hours
Time frame: approximately 0-12 hours post operatively
Average Pain Score 12-24 Hours
Time frame: approximately 12-24 hours post operatively
Average Pain Score 24-48 Hours
Time frame: approximately 24-48 hours post operatively
Post-Operative Nausea
Time frame: 12 hours, 24 hours, and 48 hours
Length of Stay in Hospital
Time frame: Arrival at hospital until discharge from hospital, approximately 2 days
Patient Satisfaction With Pain Control at Time of Hospital Discharge
Time frame: approximately 1-2 days post-operatively
Patient Satisfaction With Pain Control at Postoperative Visit
Time frame: approximately 30 days post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Andrew W Gorlin, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Standard therapy in people with Laparoscopic Gastric Bypass Surgery and Ketamine, run by Mayo Clinic 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 10 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 29 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Apr 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?
Total Cumulative Perioperative Opioid Dose (time frame: approximately 48 hours after induction of anesthesia). 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 29 Apr 2021.