CompletedPhase 2ketamine

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

Sponsored by NYU Langone Health

NCT ID
NCT02452060
Target Enrollment
90 participants
Start Date
2014-10
Est. Completion
2017-04-13

About This Study

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.

Conditions Studied

PainPostoperative Depression

Interventions

  • Ketamine
  • Placebo Comparator

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source