Ketamine, Minor Surgical Procedure, Total Mood Score, Woman
Conditions
Keywords
ketamine, POMS questionnary, acute Mood, fractional curettage, propofol
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.
Interventions
DRUGKetamine
0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered
OTHERSaline
0.09% Saline (0.05ml/kg) intravenously administered
Sponsors
Istanbul Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing total mood scores of both groups using Profile of Mood States (POMS) Questionnaire. | Total Mood Score measured 120 minutes after surgery | The Turkish version of Profile of Mood States (POMS) is an validated instrument that measures mood using a 58-item questionnaire with each item rated using a response scale of five categories ranging from not at all to very strong. Higher score indicates worse mood.As a global measure of affective state, a total mood score (TMS) is calculated by combining the negative mood subscore (NMS) totals (fatigue-inertia, anger-hostility, confusion-bewilderment, depression-dejection, tension-anxiety,) and subtracting the positive mood subscore (PMS) (vigor-activity). The minimum value of TMS is -24, the maximum value is+177. |
| Impact of clinical variables on total mood scores using Profile of Mood States (POMS) | 120 minutes after surgery | We perform multiple linear regression analyses to examine the independent predictors of changes in postoperative TMS in the entire study group, patients in group-K and group-C, separately. Postoperative TMS is the dependent variable; menopausal status, parity, educational level, body mass index (BMI) and preoperative TMS are independent variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale for pain assessment | 120 minutes after surgery | Numeric rating scale score (NRS) is commonly used for measuring pain intensity. It is scored from 0-10; 0 means no pain and 10 is the worst pain imaginable. NRS assessed at the 120 minutes postoperatively |
| Systolic blood pressure | immediately before surgery and 120 minutes after surgery | Measuring systolic blood pressure (mmHg) before surgery and 120 minutes after surgery and comparing values between and within group K and group C |
| diastolic blood pressure | immediately before surgery and 120 minutes after surgery | Measuring diastolic blood pressure (mmHg) before surgery and 120 minutes after surgery and comparing values within groups and comparing values between and within group K and group C |
| heart rate | immediately before surgery and 120 minutes after surgery | Measuring number of heart beats per minute before surgery and 120 minutes after surgery and comparing values within groups and comparing values between and within group K and group C |
| The Michigan Sedation Score assessment | immediately Before surgery, 60 minutes after surgery and 120 minutes after surgery | Comparing depth of sedations of two groups using the University of Michigan Sedation Scale (UMSS). This sedation scale ranges from zero to four with higher numbers indicating deeper sedation. |
| Diplopia | 120 minutes after surgery | Presence of absence of diplopia reported in clinical records electronic database by nurse or physician within time frame |
| Headache | 120 minutes after surgery | Presence of absence of headache reported in clinical records electronic database by nurse or physician within time frame |
| Psychedelic phenomena | 120 minutes after surgery | Presence of absence of psychedelic phenomena reported in clinical records electronic database by nurse or physician within time frame |
| Nausea | 120 minutes after surgery | Presence of absence of nausea reported in clinical records electronic database by nurse or physician within time frame |
| Vomiting | 120 minutes after surgery | Presence of absence of vomiting reported in clinical records electronic database by nurse or physician within time frame |
| Patient satisfaction | 120 minutes after surgery | Evaluation of patient satisfaction 120 minutes after surgery. Satisfaction is rated on a scale of 1 to 4 (1 perfect, 2 good, 3 moderate, and 4 bad). |
| Physician satisfaction | 120 minutes after surgery | Evaluation of physician satisfaction 120 minutes after surgery. Satisfaction is rated on a scale of 1 to 4 (1 perfect, 2 good, 3 moderate, and 4 bad). |
Countries
Turkey (Türkiye)
Outcome results
None listed