Clinical trial NCT05752110: Effects of Subanesthetic Dose of Ketamine Given on Postoperative Mood in Patients Undergoing Fractional Curettage
Official title: Does Subanesthetic Dose of Ketamine Given at Induction of Anesthesia Improve Postoperative Mood In Women Undergoing Fractional Curettage? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ketamine
Minor Surgical Procedure
Total Mood Score
Woman
Keywords: ketamine
POMS questionnary
acute Mood
fractional curettage
propofol
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-02
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When given intravenously in doses below 1.2mg/kg, ketamine has been shown to work as an antidepressant. Ketamine is a common induction drug used during general anesthesia. It is known to reduce postoperative pain in this instance. Limited studies have evaluated the effect of a single subanesthetic dosage of ketamine administered as an adjunct to general anesthesia on acute mood states in patients undergoing minor surgery. The aim of this randomized controlled study was to examine if a single intravenous administration of 0.5 mg/kg ketamine given at the induction of propofol/fentanyl anesthesia has an effect on acute mood states before the discharge of women undergoing fractional curettage.

Detailed description: Women admitted for fractional curettage between the ages of 18 and 75 were asked if they would like to participate in the study. Exclusion criteria included uncontrolled hypertension, pregnancy, history of psychologic disorders, use of brain-affecting medicines, substance abuse, seizure disorders, or ketamine allergy. After receiving informed consent, the patient would be given a POMS questionnaire. The participants were then assigned randomly to one of two groups. Group A will receive ketamine intravenously at a dose of 0.5 mg/kg as part of the induction process for general anesthesia. In addition to their anesthetic, Group B will get the same amount of saline instead of ketamine. Patients were treated by a different anesthetic professional (who is blinded to the group the patient is in). All other induction medicines were administered at the discretion of the anesthesiologist. Two hours after the surgery, participants were again administered the POMS questionnaire, questioned about their pain level, and their data sheet was updated accordingly. During the trial, the levels of sedation, systolic and diastolic blood pressures and heart rate were measured. In addition, any adverse events were documented.

Eligibility criteria: Inclusion Criteria:

* consecutive patients (\>18 years) undergoing fractional curettage

Exclusion Criteria:

* American Society of Anesthesiologists' physical status ≥ 3
* History of psychological disorders
* Use of drugs affect central nervous system
* Substance abuse
* Chronic pain
* Pregnancy
* Seizure disorders
* Cardiovascular, hepatic or renal disease

Primary outcomes:
measure: Comparing total mood scores of both groups using Profile of Mood States (POMS) Questionnaire.
timeFrame: Total Mood Score measured 120 minutes after surgery
measure: Impact of clinical variables on total mood scores using Profile of Mood States (POMS)
timeFrame: 120 minutes after surgery
Secondary outcomes:
measure: Numeric rating scale for pain assessment
timeFrame: 120 minutes after surgery
measure: Systolic blood pressure
timeFrame: immediately before surgery and 120 minutes after surgery
measure: diastolic blood pressure
timeFrame: immediately before surgery and 120 minutes after surgery
measure: heart rate
timeFrame: immediately before surgery and 120 minutes after surgery
measure: The Michigan Sedation Score assessment
timeFrame: immediately Before surgery, 60 minutes after surgery and 120 minutes after surgery
measure: Diplopia
timeFrame: 120 minutes after surgery
measure: Headache
timeFrame: 120 minutes after surgery
measure: Psychedelic phenomena
timeFrame: 120 minutes after surgery
measure: Nausea
timeFrame: 120 minutes after surgery
measure: Vomiting
timeFrame: 120 minutes after surgery
measure: Patient satisfaction
timeFrame: 120 minutes after surgery
measure: Physician satisfaction
timeFrame: 120 minutes after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
state: Fatih
city: Istanbul
country: Turkey
facility: IstanbulTRH
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Mehmet TOPTAS, Ass.Prof.Dr
role: STUDY_CHAIR
References: