Clinical trial NCT02452060: Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy
Official title: Randomized, Double-blind, Placebo Controlled Study on the Effect of a Single Postoperative Administration of Low Dose Ketamine After Gastric Bypass and Gastrectomy Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Postoperative Depression
Keywords: perioperative period
pain
gastric bypass
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adults, \>18 years, \<65 years, who will undergo gastric bypass or sleeve gastrectomy.
2. Subject is non-lactating and is either:

   * Not of childbearing potential; or
   * Of childbearing potential but is not pregnant at time of baseline as determined by pre-operative pregnancy testing.
3. Subject is ASA physical status 1, 2, or 3.
4. Subject who is deemed medically stable

Exclusion Criteria:

1. \<18 years of age; \>65 years of age
2. Pregnant or breastfeeding
3. Does not speak or understand English (the study forms used are copy-righted in English)
4. Cognitively impairment (by history) or clinical signs of altered mental status
5. History of misuse or abuse of ketamine
6. History of chest pain or chest pain in the PACU
7. Use of a medication that interferes with metabolism of ketamine within the last 24 hours
8. A diagnosis of schizophrenia and/ or a history of chronic antipsychotic medication use
9. History of head trauma
10. History of intracranial mass or hemorrhage
11. History of stroke
12. History of cardiac arrhythmia
13. Subject for whom ketamine is contraindicated
14. Unwillingness to give informed consent according to HIC guidelines

Primary outcomes:
measure: Change in Pain Scores
timeFrame: Baseline (DOS) to 7 days (Post Op)
Secondary outcomes:
measure: Length of Stay During Hospitalization
timeFrame: 8 days
Other outcomes:
measure: Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion
timeFrame: 8 Days
measure: Opioid Usage Per Day Throughout the Hospital Stay
timeFrame: 8 days
measure: Time to Out of Bed to Chair (OOB)
timeFrame: 7 Days
measure: Spirometry Use 4 Hours After the Termination of Ketamine Infusion
timeFrame: 1 day
measure: Change in Serum Level of IL-1 After Ketamine Infusion
timeFrame: 1 day
measure: Survey Scores - McGill's Short Form
timeFrame: Pre-op,Day of Surgery through Post-op Day 8
measure: Survey Scores - Becks Depression Index (BDI)
timeFrame: Pre-op,Day of Surgery through Post-op Day 8
measure: Survey Scores - QoR15
timeFrame: Pre-op,Day of Surgery through Post-op Day 8
measure: Survey Scores - MADRS
timeFrame: Pre-op,Day of Surgery through Post-op Day 8
measure: Change in Serum Level of IL-6 After Ketamine Infusion
timeFrame: 1 day
measure: Change in Serum Level of TNF-α After Ketamine Infusion
timeFrame: 1 day
measure: Change in Serum Level of BDNF After Ketamine Infusion
timeFrame: 1 day
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Jing Wang, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.