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

NCT ID: NCT02452060

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-04-13

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.

Conditions

Pain; Postoperative Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

treatment/placebo

saline infusion

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: OTHER

0.4mg/kg infusion

treatment

ketamine (0.4mg/kg)

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

0.4mg/kg infusion

Interventions

Ketamine

0.4mg/kg infusion

Intervention Type: DRUG

Placebo Comparator

0.4mg/kg infusion

Intervention Type: OTHER

Other Intervention Names

ketalar; Saline Infusion

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Wang, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30095550 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-00472

Identifier Type: -

Identifier Source: org_study_id