Comparison of Ketamine Plus Dexamethasone Versus Ketamine Alone for Prevention of Severe Shivering After Spinal Anesthesia in Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- number of shivering episodes
研究概览
简要总结
Shivering is one of the most distressing events of the birth experience for patients. Shivering that occurs with spinal anesthesia is a frequent event, with a reported incidence of up to 50-65%. (1) This may be normal thermoregulatory shivering in response to core hypothermia or may result from the release of cytokines by the surgical procedure. (2-4) shivering is graded with a scale described by Bedside Shivering Assessment Score (BSAS). (3, 4) Most of the literature recommends a variety of non-pharmacological and pharmacological options for the prevention and treatment of shivering after spinal anesthesia. Pethidine, tramadol, clonidine, dexmedetomidine, biogenic amines (serotonin 5-HT3 receptor antagonist), low-dose ketamine, dexamethasone, and magnesium sulfate were used as pharmacological agents. (5) Intravenous (IV) ketamine 0.25 mg/kg was approved as effective in the prevention and treatment of shivering after regional anesthesia and can be used in patients undergoing cesarean sections without adverse effects on the baby. (5) Ketamine is a competitive N-methyl-D-aspartate receptor antagonist, and it is believed that its anti-shivering action is due to non-shivering thermogenesis, either by effect on the hypothalamus or by the β-adrenergic effect of norepinephrine. (6) In spite of the approved effectiveness of ketamine in this issue, moderate to severe shivering (grade ≥ 2) still occurs with an incidence that cannot be ignored. (7-9) Dexamethasone was also approved as an alternative pharmacological agent for the prevention and treatment of mild and moderate shivering. (10) Dexamethasone prevents shivering by regulating immune response and decreasing the temperature gradient between skin and body core via its anti-inflammatory action and inhibition of the release of vasoconstrictors and pyrogenic cytokines. We hypothesize that addition of dexamethasone (0.1 mg\kg) to low dose ketamine (0.25 mg\kg) will be more effective in prevention of severe shivering after spinal anesthesia with cesarean section with minimal sedation of the mother and negligible effect on the baby. This can be applicable in resource-limited settings.
详细描述
- Preoperatively, a trained anesthetist will assess the patients regarding the age, height; weight. Medical history, medications, laboratory investigation, as well as the patient's airway. Fasting hours will be reviewed(8 hours) In the operating room; temperature will be maintained at 24 °c -26° c by adjusting the temperature setting of the air conditioner.
- Routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied & axillary temperature will be recorded; then intravenous access (18-G cannula) will be inserted and pre-medication ranitidine 40 mg will be administered.
- Baseline vitalsigns will be recorded in the supine position. Ringer lactate infusion (which is kept at room temperature 24°c -26°c) will be started at a rate of 10 ml/kg for the first 30 minutes then reduced to 6 ml/kg till the end of the surgery.
B. drug preparation:
An independent research assistant will be responsible for opening the envelopes and preparing the study drug with no further involvement in the study. The attending anesthetist and data collector will be blinded to the study group.
Group K (ketamine):
syringe (1): the ketamine syringe, dilute 25 mg ketamine in 10 ml saline to have a concentration of 2.5mg/ml. The dose will be 0.25 mg/kg, so we will give 0.1ml/kg of the syringe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria
- •pregnant females
- •aged 18 to 45 years
- •ASA physical status II
- •elective Cesarean sections under spinal anesthesia
- •Exclusion criteria
- •Contraindications for spinal anesthesia
- •Emergency cesarean sections
- •Patient with initial body temperature >38°c or <36°c
- •Allergy to any of the drugs used in the study
- •Pre Existing neurological diseases (particularly those that wax and wane, e.g.multiple sclerosis)
- •Thrombocytopenia and coagulation disorders.
- •Severe stenotic heart disease.
排除标准
- 未提供
研究组 & 干预措施
ketamine group
Group K (ketamine):
syringe (1): the ketamine syringe, dilute 25 mg ketamine in 10 ml saline to have a concentration of 2.5mg/ml. The dose will be 0.25 mg/kg, so we will give 0.1ml/kg of the syringe.
syringe (2): saline syringe 10 ml saline in 10 ml syringe. (for double blinded technique). we will give 0.1ml/kg of the syringe.
干预措施: Ketamine Hydrochloride (Drug)
ketamine dexamethasone group
Group KD (ketamine plus dexamethasone):
Syringes (1): the ketamine syringe, dilute 25 mg ketamine in 10 ml saline to have a concentration of 2.5mg/ml. The dose will be 0.25 mg/kg, so we will give 0.1ml/kg of the syringe.
Syringe (2): dexamethasone syringe, 10 mg dexamethasone will be diluted with 10 ml saline in 10 ml syringe, concentration will be 1mg/ml. the dose will be 0.1 mg/kg, so we will give 0.1ml/kg of the syringe.
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
number of shivering episodes
时间窗: the whole procedure and for 60 minutes postoperative
● the number of shivering episodes scored ≥3 will be recorded.
次要结局
- APGAR score of the baby(5 minutes)
- sedation score of the mother(120 minutes)
- hemodynamics(120 minutes)
研究者
Amany Ahmed Eissa
lecturer of anesthesia& ICU
Kasr El Aini Hospital