NCT02452060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Oct 2014

Typical duration for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

April 16, 2015

Results QC Date

July 12, 2019

Last Update Submit

March 2, 2020

Conditions

PainPostoperative Depression

Keywords

perioperative periodpaingastric bypass

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Length of Stay During Hospitalization

    8 days

Other Outcomes (12)

  • Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion

    8 Days

  • Opioid Usage Per Day Throughout the Hospital Stay

    8 days

  • Time to Out of Bed to Chair (OOB)

    7 Days

  • +9 more other outcomes

Study Arms (2)

treatment/placebo

PLACEBO COMPARATOR

saline infusion

Other: Placebo Comparator

treatment

EXPERIMENTAL

ketamine (0.4mg/kg)

Drug: Ketamine

Interventions

KetamineDRUG

0.4mg/kg infusion

Also known as: ketalar
treatment
Placebo ComparatorOTHER

0.4mg/kg infusion

Also known as: Saline Infusion
treatment/placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, \>18 years, \<65 years, who will undergo gastric bypass or sleeve gastrectomy.
  • 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.
  • Subject is ASA physical status 1, 2, or 3.
  • Subject who is deemed medically stable

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 30095550DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Jing Wang
Organization
NYU Langone Medical Center
jing.wang@nyulangone.org
212-460-0176

Study Officials

  • Jing Wang, MD, PHD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

May 22, 2015

Study Start

October 1, 2014

Primary Completion

April 13, 2017

Study Completion

April 13, 2017

Last Updated

March 16, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-03

Locations

US(1)