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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452060
• Other study ID #: 14-00472
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2014
• Est. completion date: April 13, 2017

Study information

• Verified date: March 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Pain
• Postoperative Depression

Intervention

Drug:
• Ketamine
0.4mg/kg infusion

Other:
• Placebo Comparator
0.4mg/kg infusion

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Opioid Usage Per Day Throughout the Hospital Stay	recorded from medical chart	8 days
Other	Time to Out of Bed to Chair (OOB)	Patient will be asked to record and report the time to OOB	7 Days
Other	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
Other	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
Other	Survey Scores - McGill's Short Form	Change in survey scores -- McGill's short form	Pre-op,Day of Surgery through Post-op Day 8
Other	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
Other	Survey Scores - QoR15	Change in scores for Quality of Recovery 15 - QoR15	Pre-op,Day of Surgery through Post-op Day 8
Other	Survey Scores - MADRS	Change in scores for MADRS	Pre-op,Day of Surgery through Post-op Day 8
Other	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
Other	Change in Serum Level of TNF-a 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
Other	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
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.	Baseline (DOS) to 7 days (Post Op)
Secondary	Length of Stay During Hospitalization	LOS will be recorded from medical record.	8 days