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

Ketamine

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.

Intervention / Treatment

  • Ketamine (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 (DRUG)
    equal volume of normal saline mixed to intravenous patient controlled analgesia device

Condition or Disease

  • Postoperative Nausea and Vomiting

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 20 Years to 65 Years
    Enrollment: 50 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Jan 01, 2010
    Primary Completion: Apr 01, 2012 ACTUAL
    Completion Date: Apr 01, 2012 ACTUAL
    Study First Posted: Jul 14, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Mar 04, 2014

    Sponsors / Collaborators

    Lead Sponsor: Yonsei University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    South Korea
    Seoul, South Korea

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Incidence of postoperative nausea and vomiting within 48 hrs after surgery

    More Details

    NCT Number: NCT01394406
    Other IDs: 4-2009-0670
    Study URL: https://clinicaltrials.gov/study/NCT01394406
    Last updated: Sep 29, 2023