The Effects of Combination of Intravenous Dexamethasone and Ketamine on Change of Postoperative Mood in Patients Undergoing Laparoscopically Assisted Gynecologic Surgery.
Overview
- Phase
- Phase 4
- Intervention
- Ketamine Hydrochloride, dexamethasone, and combination of two drugs
- Conditions
- Depressive Symptoms
- Sponsor
- Wonkwang University Hospital
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- The change of patient health questionnaire (PHQ)-9 scores
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Ketamine and dexamethasone have been known to be effective postoperative pain. Many studies also have reported these two drugs might change mood such as depression. This study aimed to investigate the effect of each drug individually with their combination on perioperative change of mood in patients undergoing gynecologic surgery
Detailed Description
After receiving by IRB approval and obtaining informed consent from patients, 93 patients who are aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients will be randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receive dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receive ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.
Investigators
Cheol Lee
Chief professor, principal investigator
Wonkwang University Hospital
Eligibility Criteria
Inclusion Criteria
- •patients who were scheduled for laparoscopic gynecologic surgery
Exclusion Criteria
- •Patients with hepatic and renal insufficiency, history of allergy to the study drugs, previous gastric ulcer, diabetes mellitus, and receiving analgesic, antiemetic, antihistamine, steroids or psychiatric drugs within 24 hours before surgery steroids
Arms & Interventions
Group K (n = 31)
will receive a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, at 5 minutes after the induction of anesthesia
Intervention: Ketamine Hydrochloride, dexamethasone, and combination of two drugs
Group D (n = 31)
will receive dexamethasone 0.5 mg/kg i.v. plus 2 ml normal saline, at 5 minutes after the induction of anesthesia
Intervention: Ketamine Hydrochloride, dexamethasone, and combination of two drugs
Group KD (n = 31)
will receive ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v., at 5 minutes after the induction of anesthesia
Intervention: Ketamine Hydrochloride, dexamethasone, and combination of two drugs
Outcomes
Primary Outcomes
The change of patient health questionnaire (PHQ)-9 scores
Time Frame: at the 1st day after surgery
Anesthesiologist performed the assessment of perioperative depressed mood change with use of Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day) with a total score ranging from 0 to 27; 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depressed mood
Secondary Outcomes
- postoperative visual analog scale (VAS) for pain(for 48 h after surgery)
- patient controlled analgesia (PCA) consumption(for 24 h after surgery)