NCT01394406

Brief Summary

Ketamine added to intravenous patient-controlled analgesia may be effective on prevention of postoperative nausea and vomiting by reducing opioid requirement after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

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

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

2.2 years

First QC Date

July 13, 2011

Last Update Submit

March 4, 2014

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative nausea and vomiting

    within 48 hrs after surgery

Study Arms (2)

Ketamine group

EXPERIMENTAL
Drug: Ketamine

Saline group

PLACEBO COMPARATOR
Drug: Saline

Interventions

KetamineDRUG

ketamine 3 mg/kg mixed to intravenous patient controlled analgesia device (fentanyl 20 mcg/kg. total volume 180 ml, basal infusion 2 ml, bolus 2ml, lock-out 15 min)

Ketamine group
SalineDRUG

equal volume of normal saline mixed to intravenous patient controlled analgesia device

Saline group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking female patients undergoing elective lumbar spinal surgery
  • Age 20-65
  • American Society of Anesthesiologists physical status classification I or II

You may not qualify if:

  • Antiemetic within 24 hrs, Taking Steroids, Opioids within 1 week
  • Psychiatric disease, Active drug or alcohol abuse
  • GI motility disorder, severe renal/ hepatic disease
  • insulin-dependent DM
  • admission to ICU after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

January 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

KR(1)