NCT01724983

Brief Summary

Ketamine may improve recovery from bariatric surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

September 14, 2012

Last Update Submit

November 7, 2012

Conditions

Morbid Obesity

Keywords

painmooddepressionrespiration

Outcome Measures

Primary Outcomes (2)

  • pain level

    postoperatively, up to 3 months

  • mood level

    postoperatively, up to 3 months

Secondary Outcomes (7)

  • total dosages of analgesic and muscle relaxant drugs

    postoperatively, up to 3 months

  • postanesthetic recovery

    postoperatively, up to 24 hours

  • satisfaction of the patient and of the surgeon

    day 1

  • pulse oximetry saturation

    postoperatively, up to 24 hours

  • lung volumes

    postoperatively, up to 48 hours from end of surgery

  • +2 more secondary outcomes

Study Arms (2)

ketamine

EXPERIMENTAL

patients will receive ketamine at induction

Drug: ketamine

fentanyl

ACTIVE COMPARATOR

patients will receive fentanyl at induction

Drug: fentanyl

Interventions

ketamineDRUG
ketamine
fentanylDRUG
fentanyl

Eligibility Criteria

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

You may qualify if:

  • age \> 18
  • obesity (Body Mass Index \> 30)
  • ASA classificazion \< 4
  • candidate to bariatric surgery

You may not qualify if:

  • known or presumed pregnancy
  • previous surgery on the airway, esophagus or stomach
  • uncontrolled psychiatric symptomatology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera

Padua, PD, 35121, Italy

Location

MeSH Terms

Conditions

Obesity, MorbidPainDepressionRespiratory Aspiration

Interventions

KetamineFentanyl

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsBehavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ulderico Freo, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

November 12, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

IT(1)