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临床试验/NCT01651988
NCT01651988已完成4 期

EFFICACY OF KETAMINE-PROPOFOL COMBINATION FOR SHORT SURGICAL PROCEDURES

Universidad de Cartagena0 个研究点目标入组 77 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
77
主要终点
EFFICACY OF KETAMINE-PROPOFOL FOR SHORT SURGICAL PROCEDURES

研究概览

简要总结

OBJECTIVE: To determine the efficacy of ketamine-propofol anesthesia in a mixture 1:2 (1 mg of ketamine per 2 mg of propofol) for short minimally invasive surgical procedures.

METHODS: The investigators performed a prospective study through randomization of 77 patients undergoing short surgical procedures in two study groups: one received a mixture of ketamine-propofol in a 1:1 ratio, and the other received a 1:2 mixture. Data were stored in an Excel spreadsheet and analyzed using the statistical program Epi-Info (TM) 3.5.3. The investigators performed the comparison of qualitative and quantitative variables.

KEY WORDS: ketamine, propofol, anesthesia.

详细描述

In recent years there has been particular interest in ketamine-propofol for sedation of patients who are candidates for short minimally invasive surgical procedures. In some centers in Canada and the U.S. is, in fact, the first choice of sedation in the ED. There are also publications of their usefulness for pediatric procedures, interventional radiology, hematology, oncology, neurosurgery, ophthalmology, orthopedic surgery, CABG, burn patients, gastroenterology, etc.; its benefits as mixed anesthetic technique in patients with neuraxial anesthesia are recognized. Around this, the literature is generous to provide us with evidence to use it in our daily practice.

There is no precise definition of what the ketofolis. Generally refers to the 50:50 mixture of ketamine and propofol, 0.5 mg / kg of each. However, a broader definition considered that ketofol is the combination of ketamine and propofol, regardless of the ratio to each other (the initial dose of each can be scaled up to 3 mg / kg). When they are used in infusion, the dose is 100μg/kg/min.

The combination of ketamine and propofol offers advantages from a theoretical viewpoint, and as already shown, from a clinical standpoint. Ketamine-propofol technique simulates the conditions of general anesthesia because the patient is still unconscious, and although they should be available for when needed, saves anesthetic equipment as endotracheal tubes, laryngeal masks, anesthesia machine, etcetera. Avoid also the risk of malignant hyperthermia by halogenated because the patient is not exposed to pure technical inhalation or balanced techniques. Guitar proposed the ketamine-propofol mixture in 1991, however, was Friedberg who first published his benefits March 26, 1992. Friedberg was based on the technique of Vinnik using ketamine-diazepam for outpatient cosmetic procedures performed in the office. Ketamine is an aryl cyclohexamine (2-0-chlorophenyl-2-methylamino cyclohexanone) synthesized in 1961, with sedative, amnesic and analgesic properties, acting as NMDA receptor antagonist and agonist μ and σ opioid receptors. It starts to act at the first minute after intravenous application. Its duration of action is 15-30 min intravenously; the elimination half-life is 2-3 hours. Is soluble in water and lipophilic, which allows its administration by multiple routes. At low doses is primarily an analgesic and mild sedative, at higher doses produced a catatonic dissociated state which level of sedation is not increased with subsequent doses. Ketamine should be dosed based on ideal body weight and infused in 1 to 2 minutes.

It has been used extensively in health institutions with limitations for patient monitoring or limitations to address advanced airway devices, because it preserves airway reflexes, indeed, patients can swallow even if they are completely dissociated. Ketamine also increases blood pressure and myocardial oxygen demand by stimulating the cardiovascular tone by inhibiting the reuptake of catecholamines centrally. Ketamine is a respiratory stimulant, but may cause transient respiratory depression and even apnea during the first 3 minutes of administration. This problem is most often observed when the drug is administered rapidly or in association with other respiratory depressants such as benzodiazepines. It also produced laryngospasm in 0.4% of a large series of patients, so initially was contraindicated for intraoral procedures, but today it is still used for dental procedures.

Of the 11,589 children in the meta-analysis of Green who were administered ketamine, only 2 (0.017%) required intubation for laryngospasm. Other adverse effects of ketamine include feelings of dissociation from the body, unpleasant dreams, hallucinations or illusions, delusions, etc. Produces electrophysiological dissociation between neocortex, thalamus and limbic system, stimulation of the hippocampus and other subcortical nuclei, or the depression of the visual and auditory nuclei, which would lead to the misperception of external stimuli.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient scheduled for minimally invasive procedures less than an hour to complete: reduction of dislocations and fractures, lavage and debridement of ulcers, drainage of abscesses, removal of osteosynthesis material, hernia umbilical, thoracotomies, circumcision, curettage, suturing tissue soft, burn care, etc.
  • Patients who have not eaten solid food within 8 hours before or liquids in the two hours before
  • Be an adult or emancipated minor

排除标准

  • An acute lung infection
  • Procedures involving stimulation of the posterior pharynx
  • Coronary heart disease, CHD, and angina or suspected aortic dissection
  • History of uncontrolled hypertension or BP > 140/90mmHg
  • Injury cerebral focal neurological deficit or loss of consciousness
  • Mass in CNS, hydrocephalus or other conditions with increased intracranial pressure.
  • Glaucoma or eye damage
  • History of porphyrias
  • Prior hyperthyroidism or thyroid hormone replacement
  • Pregnancy or lactation Major psychiatric disorder
  • Previous mild allergic reaction to ketamine, propofol, lidocaine, or egg albumin
  • Patient who refuses to provide informed consent

研究组 & 干预措施

Ketofol 1:1

Active Comparator
  1. Anesthesia-sedation KETOFOL 1-1: Two milligrams per kilogram of ketamine plus two milligrams per kilogram of propofol in a solution 1:1 (one milligram of ketamine per one milligram of propofol) was given to those patients randomly asigned to this group, who were scheduled for any short surgical procedures previously defined in the inclusion criteria.

干预措施: Ketamina-Propofol Combination (Drug)

Ketofol 1:2

Experimental
  1. Anesthesia-sedation KETOFOL 1-2: One milligram per kilogram of ketamine plus two milligrams per kilogram of propofol in a solution 1:2 (one milligram of ketamine per two milligrams of propofol) was given to those patients randomly asigned to this group, who were scheduled for any short surgical procedure previously defined in the inclusion criteria.

干预措施: Ketamina-Propofol Combination (Drug)

结局指标

主要结局

EFFICACY OF KETAMINE-PROPOFOL FOR SHORT SURGICAL PROCEDURES

时间窗: 7 months

Sedation / analgesia was considered successful if the procedure was completed without the need for other anesthetic drugs are different from the protocol, and yes no adverse effects to oblige the completion of the procedure. Apnea was defined as cessation of breathing for at least 20 seconds. Hypotension was defined as 20% decrease in mean arterial pressure. Bradycardia was defined as a pulse of less than two standard deviations below normal values defined by the American Heart Association (AHA_ for its acronym in Ingles_). Hypoxia was defined by an oxygen saturation of less than 90%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ricardo Poveda Jaramillo

Anesthesiology Resident

Universidad de Cartagena

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