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NCT01394406 Clinical Trial

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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01394406
Other study ID # 4-2009-0670
Secondary ID
Status Completed
Phase Phase 4
First received July 13, 2011
Last updated March 4, 2014
Start date January 2010
Est. completion date April 2012

Study information
Verified date March 2014
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative nausea and vomiting within 48 hrs after surgery No
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