Ketofol (Ketamine and Propofol) Versus Propofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Security - Hypoventilation / Respiratory Depression
研究概览
简要总结
This study is a double blind randomized controlled trial. The investigators randomized ASA III and IV patients who underwent cholangiopancreatography. The investigators gave Propofol or Ketofol and compared the outcomes. The primary outcome was security (respiratory depression / hypoventilation).
详细描述
Randomization is performed by the nurse responsible for preparing the anesthesia drugs. The nurse randomly removes an envelope from a previously prepared container with as many envelopes as the number of patients calculated for the sample. Each envelope, which will be sealed, contains the branch to which the patient belongs (propofol or ketofol) and instructions for the preparation of the respective drugs.
The sample was calculated for a significance level of 5% and a test power of 95%, assuming that, on average, the primary outcome of this study - respiratory depression - is observed in 3% of the population undergoing sedation with ketofol and to 25% of patients undergoing sedation with propofol. The result of the calculation includes 51 patients for each branch of the study (considering the one-tailed hypothesis test).
Data collection is expected to take place over 5 months, taking place between October 2016 and March 2017.
The study is designed to be blinded to the patient and the anesthesiologist/investigator.
The anesthesia nurse, after preparing the drugs according to the instructions on the envelope containing the branch of the study to which the patient belongs, should label each syringe in a non-committal manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old
- •ASA III and IV
- •Submitted to retrograde cholangiopancreatography
排除标准
- •Patient refuse
- •ASA I, II and V
- •Ketamine contraindications
- •Allergies to Propofol, Ketamine, dexamethasone, paracetamol, metamizole, ondanseteon or other.
- •General anesthesia necessary I
- •Incapacitaty to sign or absence of patient legal representation.
研究组 & 干预措施
Propofol
ASA Standard monitorization and nasal spectacle capnography (OC) were used. Supplementary supply of O2 is placed at 2-3 L/min also by OC.
The drugs were randomized of the study begins. The investigators didn't know whether ketamine is present in syringes prepared with propofol or not, acting in the same way for both drug combinations.
Sedation was performed with:
- Propofol: induction with a bolus of 1% propofol (10mL syringe) administered at a dose of 0.75mg/kg; maintenance with 1% propofol infusion (20mL syringe), at an infusion rate of 6-7mg/kg/h.
In both arms:
- 4 mg of I.V. dexamethasone were administered.
- At the beginning of the procedure and atropine and ephedrine were prepared.
- At the end of the procedure, paracetamol I.V. 15mg/kg was administered.
- If the patient reports VAS>3 pain in recovery, metamizole magnesium 15mg/kg is also administered.
- In case of post-procedure nausea and/or vomiting, 4 mg of ondansetron would be administered as a rescue.
干预措施: Profofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients (Drug)
Ketofol
- Sedation with ketofol in a 1:4 dilution: induction of sedation with bolus of ketofol (dilution containing 9.5 mL of 1% propofol + 0.5 mL of 5% ketamine) (10mL syringe), administered at a dose of 0.75 mg/kg; maintenance with ketofol infusion (dilution containing 19 mL of 1% Propofol + 1 mL of 5% Ketamine), (20mL syringe), at an infusion rate of 6-7mg/kg/h.
The dose used for bolus induction of sedation in both arms of the study is titrated to the needs of each individual patient, although the target approximates the usual recommended dose. If a propofol or ketofol syringe is insufficient considering the patient's weight, another syringe will be prepared with exactly the same dilution as the first.
The study was always blind to the investigators.
干预措施: Ketofol for Sedation in Cholangiopancreatography for ASA III and ASA IV Patients (Drug)
结局指标
主要结局
Security - Hypoventilation / Respiratory Depression
时间窗: Intraprocedure
Hypoventilation / Respiratory Depression defined as: Need for airway management (mandibular subluxation or other permeabilization maneuvers, use of adjuvants, need for assisted or controlled ventilation); Oxygen desaturation measured by pulse oximeter n(\<95%); Apnea (\>10 seconds)
次要结局
- Security - Intraprocedure hypotension(During the procedure and immediately after the end of procedure)
- Efficiency - Assessment of sedation level(During the procedure and immediately after the end of procedure)
- Quality - Occurrence of postoperative nausea or vomiting(In the first 24 hours after the end of the procedure)
- Efficiency - Intraprocedure opioid necessity(During the procedure and immediately after the end of procedure)
- Quality - Occurence of psychotomimetic effects(In the first 24 hours after the end of the procedure)
- Quality - Gastroenterologist satisfaction(Immediately at the end of the procedure)
- Quality - Patients satisfaction(At the end of the procedure (when the patient lucid and oriented in person, time and space) and 24 hours after the end of the procedure)
研究者
Henrique Xavier Ornelas Gouveia
Principal Investigator
Centro Hospitalar Universitário Lisboa Norte