Dexamethasone and Ketamine on Change of Postoperative Mood

Wonkwang University Hospital

Status and phase: Completed; Phase 4

Conditions: Depressive Symptoms

Treatments: Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT03194594

WonkwangUH2

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

93 participants in 3 patient groups

Group K (n = 31)

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs

Group D (n = 31)

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs

Group KD (n = 31)

Experimental group

Description:

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

Treatment:

Drug: Ketamine Hydrochloride, dexamethasone, and combination of two drugs