PainPhase 4NCT01997515
Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
A Phase 4 study testing Ketamine in people with Pain and Obesity, run by Northwestern University at 1 site in United States.
Trial summary
Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 22 Aug 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64
- surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
- ASA physical status classification I, II, III
- Body Mass Index >35kg/m2
- Fluent in English
Who cannot join
- History of allergy to protocol medications
- History of chronic opioid use
- Pregnant patients
- Drop out: Conversion to an open surgical route, patient or surgeon request.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia.
Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events.
The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.
- Being tested
- Ketamine, placebo
- Keywords
- Quality of Recovery 40 Questionaire, Pain, Hypoxia, Gastric Surgery, Obesity, Ketamine
- Medical subject headings
- Pain, Obesity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
placeboDrug
Also called Sterile .9 Normal Saline
Group P (placebo) will receive the same amount of saline.
| Study group | Role | What they receive |
|---|---|---|
| Group K (Ketamine) | Active comparator | Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight). Receives: Drug: Ketamine |
| Group P (Placebo) | Placebo comparator | Group P (placebo) will receive the same amount of saline. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 40
Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.
Measured: 24 hours
Secondary outcomes (3)
Postoperative Opioid Consumption
Total number of opioids (morphine equivalents) consumed 24 hours after surgery
Measured: 24 hours
Postoperative Pain Scores
Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).
Measured: 24 hours
Length of Hospital Stay
The subjects length of hospital stay will be recorded. Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks..
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion26 Jul 2019
- Study completion22 Aug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Yilmaz, Northwestern University
- Investigators
- Meltem Yilmaz, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997515
- Sponsor's protocol ID
- STU00081191
- Status last verified
- Oct 2019
- First submitted
- 18 Nov 2013
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin Pharmacol Ther. 2007 Nov;82(5):505-8. doi: 10.1038/sj.clpt.6100381.
PubMed 17952107
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01997515
- Acronym / sponsor ID
- STU00081191
- Keywords
- Quality of Recovery 40 Questionaire, Pain, Hypoxia, Gastric Surgery, Obesity, Ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 22 Aug 2019 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia.
Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events.
The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group K (Ketamine) | Active comparator | Drug: KetamineGroup K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight). |
| Group P (Placebo) | Placebo comparator | Drug: placeboGroup P (placebo) will receive the same amount of saline. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-64
- surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
- ASA physical status classification I, II, III
- Body Mass Index >35kg/m2
- Fluent in English
Key exclusion criteria (4 listed)
- History of allergy to protocol medications
- History of chronic opioid use
- Pregnant patients
- Drop out: Conversion to an open surgical route, patient or surgeon request.
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: KetalarGroup K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight). | Drug | Group K (Ketamine) |
| placeboAlso: Sterile .9 Normal SalineGroup P (placebo) will receive the same amount of saline. | Drug | Group P (Placebo) |
Primary outcome
Quality of Recovery 40
Time frame: 24 hours
Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.
3 secondary outcomes
Postoperative Opioid Consumption
Time frame: 24 hours
Postoperative Pain Scores
Time frame: 24 hours
Length of Hospital Stay
Time frame: Up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17952107Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin Pharmacol Ther. 2007 Nov;82(5):505-8. doi: 10.1038/sj.clpt.6100381.
- 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.
Meltem Yilmaz, MD principal investigator
Northwestern University
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 in people with Pain and Obesity, run by Northwestern University 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 4 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 7 Oct 2019. 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.
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 7 Oct 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?
Quality of Recovery 40 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997515, which also lists 1 linked publication.
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 7 Oct 2019.