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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01394406
• Date of registration: 13/07/2011
• Prospective Registration: No
• Primary sponsor: Yonsei University
• Public title: Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
• Scientific title: Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
• Date of first enrolment: January 2010
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01394406
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Postoperative Nausea and Vomiting

Intervention(s)

Drug: Ketamine

Drug: Saline

Primary Outcome(s)

Incidence of postoperative nausea and vomiting [Time Frame: within 48 hrs after surgery]

Secondary ID(s)

4-2009-0670

Source(s) of Monetary Support

Please refer to primary and secondary sponsors