Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery

NCT ID: NCT01394406

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ketamine group

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

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)

Saline group

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Ketamine

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)

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2009-0670

Identifier Type: -

Identifier Source: org_study_id

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