Dexamethasone and Ketamine on Change of Postoperative Mood
- Conditions
- Depressive Symptoms
- Interventions
- Registration Number
- NCT03194594
- Lead Sponsor
- Wonkwang University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
- patients who were scheduled for laparoscopic gynecologic surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group K (n = 31) Ketamine Hydrochloride, dexamethasone, and combination of two drugs 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 Group D (n = 31) Ketamine Hydrochloride, dexamethasone, and combination of two drugs will receive dexamethasone 0.5 mg/kg i.v. plus 2 ml normal saline, at 5 minutes after the induction of anesthesia Group KD (n = 31) Ketamine Hydrochloride, dexamethasone, and combination of two drugs 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
- Primary Outcome Measures
Name Time Method The change of patient health questionnaire (PHQ)-9 scores 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 Outcome Measures
Name Time Method postoperative visual analog scale (VAS) for pain for 48 h after surgery The VAS consisted of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients were asked to mark the position on the line corresponding to their perception of pain. The VAS score for pain was measured with intervals of 1, 6, 24, and 48 hours after surgery.
patient controlled analgesia (PCA) consumption for 24 h after surgery Each patient was administered analgesics using a PCA pump containing morphine (60 mg), ketorolac (150 mg), and ramosetron (0.6 mg) in a total volume of 100 ml of saline. This device was set to deliver a basal infusion of 2 ml/hr and bolus doses of 0.5 ml with a 15 min lockout period.
Trial Locations
- Locations (1)
WonwangUH
🇰🇷Iksan, Jeonbuk, Korea, Republic of