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

This study is currently recruiting participants.

Verified February 2012 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01394406

First received: July 13, 2011

Last updated: February 1, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 13, 2011
Last Updated Date	February 1, 2012
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 13, 2011)	Incidence of postoperative nausea and vomiting [ Time Frame: within 48 hrs after surgery ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01394406 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
Official Title ^ICMJE	Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Postoperative Nausea and Vomiting
Intervention ^ICMJE	Drug: 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) Drug: Saline equal volume of normal saline mixed to intravenous patient controlled analgesia device
Study Arm (s)	Experimental: Ketamine group Intervention: Drug: Ketamine Placebo Comparator: Saline group Intervention: Drug: Saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	May 2012
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01394406
Other Study ID Numbers ^ICMJE	4-2009-0670
Has Data Monitoring Committee	Yes
Responsible Party	Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top