Comparison Between Standalone Succinyl Choline and Rocuronium After Pretreatment With Dexmedetomidine, in Rapid Sequence Induction.
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- number of patients with excellent intubating conditions
研究概览
简要总结
Background: Rapid sequence induction is a well-established anesthetic procedure used in trauma setting and patients with full stomach. Succinyl choline has the been the drug of choice, however, it carries potential risk and sometimes fatal outcome. Aim of the study: to compare rocuronium after pre-treatment with Dexmedetomidine, to succinyl choline in providing excellent intubating conditions. Material and method: Patients were randomly allocated to one of two groups, of 120 each. Control (SS) group, patients received pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg was on induction. Experimental (DR) group, received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg on induction.
详细描述
Rapid sequence induction (RSI) is a well-established anesthetic procedure routinely used in emergency and trauma setting, and in elective situations when there is high risk of regurgitation/aspiration The ideal neuromuscular relaxant agent used for RSI should have a quick onset of action, which is a major advantage in trauma setting as it mitigates the risk of aspiration and desaturation when endotracheal intubation should be performed as early as possible. It also should have a quick offset to ensure that if trials at endotracheal intubation were unsuccessful, there would be quick neuromuscular recovery, with return to spontaneous breathing before the patient start desaturation. Moreover, it should have minimal cardiovascular or systemic side effects.
Typically, succinyl choline has been the neuromuscular agent of choice for RSI as it has the quickest onset and offset of action compared to other muscle relaxants. However, it has potentially risky- sometimes fatal- side effects that make it far from being ideal neuromuscular blocking agent in RSI.
Owing to its fast onset of action and stable hemodynamics Rocuronium, a non-depolarizing muscle blocker, has been suggested as possible alternative to succinyl choline in RSI. The standard rocuronium intubating dose of during routine anesthesia is 0.6 mg/ kg, which results in adequate intubation conditions within 60 seconds in nearly all patients.
The recommended rocuronium intubating dose during RSI anesthesia is 1.0-1.2 mg/kg, after which optimum tracheal intubation conditions are also achieved within 60 seconds in nearly all patients. If the standard dose of 0.6 mg/ kg is given on RSI of anesthesia, it is advised to wait 90 seconds before attempting to intubate the trachea.
Nevertheless, this high dose has long duration of action and may pose a risk in patients with unpredictable difficult intubation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
that the anesthetist who prepared the experimented drugs was different from the one who was responsible for administration of all medications during induction and maintenance and was responsible for the patient throughout the surgery till patient was ready to transfer to PACU. An independent third anesthetist blinded to the experimental drug administration, carried out intubation and scored intubating conditions. This independent anesthetist, was summoned to enter the operating room 45 seconds after neuromuscular relaxant was administered, when the patient was ready for intubation.
Moreover,All drugs administered in control group (saline 0.9%- succinyl; 1mg/kg) and experimental group (Dex; 1 µg/kg- rocuronium; 0.6mg/kg), were prepared in 10 mL syringe and were given via infusion pump. Saline and Dex were given over 10 minutes immediately prior to induction.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II
- •scheduled for elective surgery of more than 60 minutes duration. -
排除标准
- •Mallampati score of III or IV
- •Neuromuscular disease
- •History of allergy to the studied drugs
- •Malignant hyperthermia
- •Patients taking anticonvulsants or aminoglycoside antibiotic
- •Hepatic dysfunction
- •Renal dysfunction
- •Cardiovascular dysfunction;
- •Electrolyte imbalance
- •Morbidly obese with a body mass index (BMI) more than 30 kg/m2
- •Pregnant or nursing mothers.
研究组 & 干预措施
saline pretreatment/succinyl group (SS group).
patients receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is the intubating muscle relaxant.
干预措施: 0.9% saline and succinyl choline 1mg/ kg (Drug)
Dex pretreatment/ rocuronium group (DR group),
patients receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant.
干预措施: dexemedetomidine and rocuronium (Drug)
结局指标
主要结局
number of patients with excellent intubating conditions
时间窗: 60 seconds after muscle relaxant has been given
This score is based on triad of signs: how easy to insert the laryngoscope, the anatomical position of the vocal cords, and how patients react to the introduction of the laryngoscope
次要结局
- heart rate(at induction of anesthesia, 4 and 5 minutes after intubation.)
- mean blood pressure(at induction, 4 and 5 minutes after intubation)
研究者
Ossama Hamdy Salman
associate professor
South Valley University