Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy

Randomized, Double-blind, Placebo Controlled Study on the Effect of a Single Postoperative Administration of Low Dose Ketamine After Gastric Bypass and Gastrectomy Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative Depression
• Intervention / Treatment: Other: Placebo Comparator; Drug: Ketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: treatment/placebo; saline infusion	Other: Placebo Comparator; 0.4mg/kg infusion; Other Names: Saline Infusion
Experimental: treatment; ketamine (0.4mg/kg)	Drug: Ketamine; 0.4mg/kg infusion; Other Names: ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay During Hospitalization	LOS will be recorded from medical record.	8 days

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jing Wang, MD, PHD, NYU School of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 13, 2017
• Study Completion (Actual): April 13, 2017

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: pain; gastric bypass; perioperative period
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 14-00472