Does Subanesthetic Dose of Ketamine Given at Induction of Anesthesia Improve Postoperative Mood In Women Undergoing Fractional Curettage? A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Comparing total mood scores of both groups using Profile of Mood States (POMS) Questionnaire.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •consecutive patients (>18 years) undergoing fractional curettage
排除标准
- •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
研究组 & 干预措施
Ketamine
Received 0.5mg/kg IV single dose ketamine in addition to propofol and fentanyl anesthesia at induction period of anesthesia.
干预措施: Ketamine (Drug)
Control
Received 0.05ml/kg IV % 0.9 saline in addition to propofol and fentanyl anesthesia at induction period of anesthesia.
干预措施: Saline (Other)
结局指标
主要结局
Comparing total mood scores of both groups using Profile of Mood States (POMS) Questionnaire.
时间窗: 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)
时间窗: 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.
次要结局
- Diplopia(120 minutes after surgery)
- The Michigan Sedation Score assessment(immediately Before surgery, 60 minutes after surgery and 120 minutes after surgery)
- Headache(120 minutes after surgery)
- diastolic blood pressure(immediately before surgery and 120 minutes after surgery)
- Numeric rating scale for pain assessment(120 minutes after surgery)
- Systolic blood pressure(immediately before surgery and 120 minutes after surgery)
- Physician satisfaction(120 minutes after surgery)
- heart rate(immediately before surgery and 120 minutes after surgery)
- Psychedelic phenomena(120 minutes after surgery)
- Nausea(120 minutes after surgery)
- Vomiting(120 minutes after surgery)
- Patient satisfaction(120 minutes after surgery)
研究者
Sevim Baltali
Principal Investigator; M.D. Department of Anesthesiology, Istanbul Training and Research Hospital
Istanbul Training and Research Hospital