Back to resultsEffect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ketamine
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
Eligibility 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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine group
Saline group
Arm Description
Outcomes
Primary Outcome Measures
Incidence of postoperative nausea and vomiting
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394406
Brief Title
Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
Official Title
Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine group
Arm Type
Experimental
Arm Title
Saline group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
equal volume of normal saline mixed to intravenous patient controlled analgesia device
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Time Frame
within 48 hrs after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery
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