Dexamethasone and Ketamine on Change of Postoperative Mood

NCT03194594 | Completed Phase 4 DMC

• 1 other identifier: WonkwangUH2
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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

Conditions

Depressive Symptoms

Keywords

Ketamine, dexamethasone, mood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• postoperative visual analog scale (VAS) for pain

  for 48 h after surgery

• patient controlled analgesia (PCA) consumption

  for 24 h after surgery

Study Arms (3)

Group K (n = 31)

ACTIVE COMPARATOR

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

Group D (n = 31)

ACTIVE COMPARATOR

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

Group KD (n = 31)

EXPERIMENTAL

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

Interventions

Ketamine Hydrochloride, dexamethasone, and combination of two drugs DRUG

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.

Group D (n = 31); Group K (n = 31); Group KD (n = 31)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who were scheduled for laparoscopic gynecologic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

WonwangUH

Iksan, Jeollabuk-do, 570-711, South Korea

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine; Dexamethasone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Cheol Lee, M.D.,Ph.D

  Wonkwang UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief professor, principal investigator

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 21, 2017
• Study Start: May 2, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 12, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

KR (1)