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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
  Purpose

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


Condition Intervention Phase
Postoperative Nausea and Vomiting
 Drug: Ketamine
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of postoperative nausea and vomiting [ Time Frame: within 48 hrs after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine group 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)
Placebo Comparator: Saline group Drug: Saline
equal volume of normal saline mixed to intravenous patient controlled analgesia device

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394406

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Young-Lan Kwak, MD, Ph.D     82-2-2228-8514     ylkwak@yuhs.ac    
Contact: Jong-Wook Song, MD         sjw72331@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01394406     History of Changes
Other Study ID Numbers: 4-2009-0670
Study First Received: July 13, 2011
Last Updated: February 1, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013