Effects of Subanesthetic Dose of Ketamine Given on Postoperative Mood in Patients Undergoing Fractional Curettage
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ketamine Received 0.5mg/kg IV single dose ketamine in addition to propofol and fentanyl anesthesia at induction period of anesthesia. |
Drug: Ketamine
0,5mg/kg single dose Ketamine (0.05ml/kg) intravenously administered
Other Names:
|
| Placebo Comparator: Control Received 0.05ml/kg IV % 0.9 saline in addition to propofol and fentanyl anesthesia at induction period of anesthesia. |
Other: Saline
0.09% Saline (0.05ml/kg) intravenously administered
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Comparing the changes in acute mood assessments of both groups using Profile of Mood States (POMS) Questionnaire. [Change in Profile of Mood States Score from Baseline to 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.
Secondary Outcome Measures
- 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).
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istanbul Training and Research Hospital | Istanbul | Fatih | Turkey | |
| 2 | IstanbulTRH | Istanbul | Turkey |
Sponsors and Collaborators
- Istanbul Training and Research Hospital
Investigators
- Study Chair: Mehmet TOPTAS, Ass.Prof.Dr, Istanbul Training and Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 106/2022