Dexamethasone and Ketamine on Change of Postoperative Mood

The Effects of Combination of Intravenous Dexamethasone and Ketamine on Change of Postoperative Mood in Patients Undergoing Laparoscopically Assisted Gynecologic Surgery.

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

Study Overview

• Status: Completed
• Conditions: Depressive Symptoms
• Intervention / Treatment: Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonbuk
    • Iksan, Jeonbuk, Korea, Republic of, 570-711
      • WonwangUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

A total of 93 patients

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs; After receiving by IRB approval and obtaining informed consent from patients, 93 patients who were aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients are randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) receives a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receives dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receiveds 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.
Active Comparator: 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	Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs; After receiving by IRB approval and obtaining informed consent from patients, 93 patients who were aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients are randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) receives a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receives dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receiveds 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.
Experimental: 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	Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs; After receiving by IRB approval and obtaining informed consent from patients, 93 patients who were aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients are randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) receives a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receives dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receiveds 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of patient health questionnaire (PHQ)-9 scores	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	at the 1st day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative visual analog scale (VAS) for pain	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.	for 48 h after surgery
patient controlled analgesia (PCA) consumption	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.	for 24 h after surgery

Collaborators and Investigators

• Sponsor: Wonkwang University Hospital
• Investigators: Principal Investigator: Cheol Lee, M.D.,Ph.D, Wonkwang UH

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 12, 2017

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 18, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 18, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Ketamine, dexamethasone, mood
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Ketamine; Dexamethasone
• Other Study ID Numbers: WonkwangUH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No