Dexamethasone and Ketamine on Change of Postoperative Mood

Ketamine

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

Intervention / Treatment

  • 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.

Condition or Disease

  • Depressive Symptoms

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 93 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Double blinded

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 02, 2017 ACTUAL
    Primary Completion: Jun 01, 2017 ACTUAL
    Completion Date: Jun 12, 2017 ACTUAL
    Study First Posted: Jun 21, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 18, 2017

    Sponsors / Collaborators

    Lead Sponsor: Wonkwang University Hospital
    Responsible Party: N/A

    Location

    South Korea
    Jeonbuk, South Korea

    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.

    Participant Groups

    • 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

    • will receive dexamethasone 0.5 mg/kg i.v. plus 2 ml normal saline, at 5 minutes after the induction of anesthesia

    • 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

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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

    • 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.

    • 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.

    More Details

    NCT Number: NCT03194594
    Other IDs: WonkwangUH2
    Study URL: https://clinicaltrials.gov/study/NCT03194594
    Last updated: Sep 29, 2023