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This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery.
This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18 and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and consented during the preadmission visit prior to surgery. Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ketamine (0.4mg/kg) or matching placebo. Both men and women will be recruited, and there is no limitation as to racial and ethnic origin. In the PACU, patients will receive either 0.4mg/kg IV ketamine or placebo. All patients will also receive standard post-anesthetic monitoring and care, as well as routine care after transfer out of the PACU. Patients are followed until the date of discharge, and endpoints (see below) are collected from patient reports as well as from medical charts. During their hospital stay (and once after their discharge from the hospital), patients will fill out five questionnaires which provide estimates of their postoperative pain control, mood and function, and quality of postsurgical recovery. An additional component of the study, which is entirely optional, is to obtain patient serum samples (about two teaspoons) in the operating room and 15 minutes and 4 hours after ketamine infusion. The investigators will use these samples to assess levels of IL-1, IL-6, TNF-α, and BDNF, which are markers for pain. In addition, with patient consent, the investigators will also store serum samples for future research use to measure other cytokines and neurotrophic factors and molecular markers associated with pain and depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment/placebo | Placebo Comparator | saline infusion |
|
| treatment | Experimental | ketamine (0.4mg/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | 0.4mg/kg infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scores | VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home. | Baseline (DOS) to 7 days (Post Op) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay During Hospitalization | LOS will be recorded from medical record. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion | Length of stay and opioid usage will be recorded from electronic medical chart | 8 Days |
| Opioid Usage Per Day Throughout the Hospital Stay |
Inclusion Criteria:
Adults, >18 years, <65 years, who will undergo gastric bypass or sleeve gastrectomy.
Subject is non-lactating and is either:
Subject is ASA physical status 1, 2, or 3.
Subject who is deemed medically stable
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Wang, MD, PHD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30095550 | Derived | Wang J, Echevarria GC, Doan L, Ekasumara N, Calvino S, Chae F, Martinez E, Robinson E, Cuff G, Franco L, Muntyan I, Kurian M, Schwack BF, Bedrosian AS, Fielding GA, Ren-Fielding CJ. Effects of a single subanaesthetic dose of ketamine on pain and mood after laparoscopic bariatric surgery: A randomised double-blind placebo controlled study. Eur J Anaesthesiol. 2019 Jan;36(1):16-24. doi: 10.1097/EJA.0000000000000860. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment/Placebo | saline infusion Placebo Comparator: 0.4mg/kg infusion |
| FG001 | Treatment | ketamine (0.4mg/kg) Ketamine: 0.4mg/kg infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Comparator: 0.4mg/kg saline infusion |
| BG001 | Ketamine | Ketamine: 0.4mg/kg infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Scores | VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home. | Posted | Mean | Standard Deviation | score on a scale | Baseline (DOS) to 7 days (Post Op) |
|
|
1 Year
0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment/Placebo | saline infusion Placebo Comparator: 0.4mg/kg infusion | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness/lightheadedness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jing Wang | NYU Langone Medical Center | 212-460-0176 | jing.wang@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2017 | Jul 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo Comparator |
| Other |
0.4mg/kg infusion |
|
|
recorded from medical chart
| 8 days |
| Time to Out of Bed to Chair (OOB) | Patient will be asked to record and report the time to OOB | 7 Days |
| Spirometry Use 4 Hours After the Termination of Ketamine Infusion | Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion. | 1 day |
| Change in Serum Level of IL-1 After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | 1 day |
| Survey Scores - McGill's Short Form | Change in survey scores -- McGill's short form | Pre-op,Day of Surgery through Post-op Day 8 |
| Survey Scores - Becks Depression Index (BDI) | Change in survey scores for Becks Depression Index (BDI) | Pre-op,Day of Surgery through Post-op Day 8 |
| Survey Scores - QoR15 | Change in scores for Quality of Recovery 15 - QoR15 | Pre-op,Day of Surgery through Post-op Day 8 |
| Survey Scores - MADRS | Change in scores for MADRS | Pre-op,Day of Surgery through Post-op Day 8 |
| Change in Serum Level of IL-6 After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | 1 day |
| Change in Serum Level of TNF-α After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | 1 day |
| Change in Serum Level of BDNF After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | 1 day |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Length of Stay During Hospitalization | LOS will be recorded from medical record. | Posted | Median | Inter-Quartile Range | Days | 8 days |
|
|
|
| Other Pre-specified | Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion | Length of stay and opioid usage will be recorded from electronic medical chart | Not Posted | 8 Days | Participants |
| Other Pre-specified | Opioid Usage Per Day Throughout the Hospital Stay | recorded from medical chart | Not Posted | 8 days | Participants |
| Other Pre-specified | Time to Out of Bed to Chair (OOB) | Patient will be asked to record and report the time to OOB | Not Posted | 7 Days | Participants |
| Other Pre-specified | Spirometry Use 4 Hours After the Termination of Ketamine Infusion | Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion. | Not Posted | 1 day | Participants |
| Other Pre-specified | Change in Serum Level of IL-1 After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | Not Posted | 1 day | Participants |
| Other Pre-specified | Survey Scores - McGill's Short Form | Change in survey scores -- McGill's short form | Not Posted | Pre-op,Day of Surgery through Post-op Day 8 | Participants |
| Other Pre-specified | Survey Scores - Becks Depression Index (BDI) | Change in survey scores for Becks Depression Index (BDI) | Not Posted | Pre-op,Day of Surgery through Post-op Day 8 | Participants |
| Other Pre-specified | Survey Scores - QoR15 | Change in scores for Quality of Recovery 15 - QoR15 | Not Posted | Pre-op,Day of Surgery through Post-op Day 8 | Participants |
| Other Pre-specified | Survey Scores - MADRS | Change in scores for MADRS | Not Posted | Pre-op,Day of Surgery through Post-op Day 8 | Participants |
| Other Pre-specified | Change in Serum Level of IL-6 After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | Not Posted | 1 day | Participants |
| Other Pre-specified | Change in Serum Level of TNF-α After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | Not Posted | 1 day | Participants |
| Other Pre-specified | Change in Serum Level of BDNF After Ketamine Infusion | changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion. | Not Posted | 1 day | Participants |
| 46 |
| 0 |
| 46 |
| 9 |
| 46 |
| EG001 | Treatment | ketamine (0.4mg/kg) Ketamine: 0.4mg/kg infusion | 0 | 44 | 0 | 44 | 7 | 44 |
| nausea | General disorders | Non-systematic Assessment |
|
| euphoria | General disorders | Non-systematic Assessment |
|
| visual hallucination | Psychiatric disorders | Systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| Dysphoria | General disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |