ObesityNCT02334059
Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
A study testing Ketamine and Ketamine plus magnesium in people with Obesity, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity
- What is being tested?
- Ketamine and Ketamine plus magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 13 Mar 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing laparoscopic sleeve gastrectomy
- Consenting adults age 18-80
- ASA II to ASA III
- Ability to understand and use a PCA
- Required to be hospitalized for at least 24 hours post-op
Who cannot join
- Patient refusal
- Chronic opiate use (daily opiate use for >3 months)
- Chronic Kidney disease (Creatinine>2)
- Known allergy or adverse effect of ketamine, magnesium or hydromorphone
- Patients with documented psychiatry (Maniac or MDP) history
- Patient unable to give informed consent
- Patient with limited or no English fluency
Trial locations and contacts
1 site in 1 country.
United States1 site
Milton S.Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.
Read the detailed description
- Patient will be identified by surgeon and consented by member of the research team
- Patient will be randomized to one of three groups on the day of surgery
- Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
- The subject will receive ketamine, ketamine plus magnesium or a placebo.
- Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.
- Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively. .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine infusion plus placebo infusion of normal saline
Ketamine plus magnesiumDrug
Ketamine plus magnesium infusion
PlaceboOther
Also called Normal Saline
2 placebo infusions
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | Ketamine: 0.5 mg/kg IV dose Receives: Drug: Ketamine; Other: Placebo |
| Ketamine plus magnesium | Active comparator | Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Receives: Drug: Ketamine plus magnesium |
| Placebo | Placebo comparator | Placebo (normal saline) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Hydromorphone Use
Total hydromorphone use in 1st 24 hours post-operatively.
Measured: During surgery and 24 hours post-op
Secondary outcomes (2)
Pain Scores Using Verbal Analogue Scale (VAS)
Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.
Measured: Preoperatively and the 1st 24 hours post-op
Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startNov 2015
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
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 ObesityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjib D Adhikary, Milton S. Hershey Medical Center
- Investigators
- Sanjib Adhikary, MB, BS,MD, Principal investigator, PSHMC College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334059
- Sponsor's protocol ID
- STUDY00001623
- Status last verified
- May 2020
- First submitted
- 23 Dec 2014
- Last updated
- 1 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02334059
- Acronym / sponsor ID
- STUDY00001623
- Conditions
- Obesity
- Keywords
- opioid sparing, ketamine, obese, magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 8 Jan 2015 (estimated)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.
Detailed description
- Patient will be identified by surgeon and consented by member of the research team
- Patient will be randomized to one of three groups on the day of surgery
- Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
- The subject will receive ketamine, ketamine plus magnesium or a placebo.
- Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.
- Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamine, Other: PlaceboKetamine: 0.5 mg/kg IV dose |
| Ketamine plus magnesium | Active comparator | Drug: Ketamine plus magnesiumKetamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (normal saline) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects undergoing laparoscopic sleeve gastrectomy
- Consenting adults age 18-80
- ASA II to ASA III
- Ability to understand and use a PCA
- Required to be hospitalized for at least 24 hours post-op
Key exclusion criteria (7 listed)
- Patient refusal
- Chronic opiate use (daily opiate use for >3 months)
- Chronic Kidney disease (Creatinine>2)
- Known allergy or adverse effect of ketamine, magnesium or hydromorphone
- Patients with documented psychiatry (Maniac or MDP) history
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 infusion plus placebo infusion of normal saline | Drug | Ketamine |
| Ketamine plus magnesiumKetamine plus magnesium infusion | Drug | Ketamine plus magnesium |
| PlaceboAlso: Normal Saline2 placebo infusions | Other | Ketamine, Placebo |
Primary outcome
Total Hydromorphone Use
Time frame: During surgery and 24 hours post-op
Total hydromorphone use in 1st 24 hours post-operatively.
2 secondary outcomes
Pain Scores Using Verbal Analogue Scale (VAS)
Time frame: Preoperatively and the 1st 24 hours post-op
Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
Time frame: Intraoperative period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sanjib Adhikary, MB, BS,MD principal investigator
PSHMC College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Ketamine plus magnesium in people with Obesity, run by Milton S. Hershey Medical Center 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 5 inclusion and 7 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 1 Jun 2020. 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. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2019). 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 Hydromorphone Use (time frame: During surgery and 24 hours post-op). 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 1 Jun 2020.