Comparison of 1:1 and 1:3 ratios of ketamine-propofol admixture in rapid-sequence induction of anesthesia for emergency laparotomy: A randomized comparative study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison between 1:1 and 1:3 ratios of ketamine-propofol admixture with requirement of norepinephrine.
研究概览
简要总结
Post-induction hypotension (i.e. arterial hypotension occurring during the first 20 min after anaesthesia induction) and early intraoperative hypotension ( i.e. arterial hypotension during the first 30 min of surgery) can lead to serious organ failure and death. [1] Post-induction hypotension is closely related to the anaesthetic drugs, hence manipulation of induction agents prevents post-induction hypotension.
Patients who are in need of emergency laparotomy require a balance between adequate hypnosis and maintenance of stable hemodynamics because they are in a hemodynamically compromised state. [2] For intubation in emergency and full stomach patients, rapid sequence induction (RSI) plays an important role in avoiding the risk of aspiration of gastric contents.
Propofol is the most common hypnotic used but it is associated with hypotension whereas ketamine, even though not routinely used, produces dissociative anaesthesia and sympathetic stimulation thus providing a more stable hemodynamic profile. [3] Therefore combination of ketamine and propofol may potentially balance each other’s hemodynamic adverse effects and, therefore, offer a safer alternative of induction prior to endotracheal intubation. [4] The positive effects of each drug may indeed balance the other product downsides: sympathomimetic effects of ketamine could mitigate propofol-associated hypotension and respiratory depression, and propofol could limit the psychiatric side effects of ketamine.
We hypothesise that compared to propofol, ketamine + propofol (KETOFOL) may have a better safety profile.[2] Ketamine/Propofol mixture (KETOFOL) has less respiratory adverse effects than propofol alone in Emergency procedural sedation.[5] Currently there is paucity of literature detailing the efficacy of different admixtures of ketofol in Indian population and hence this study is designed to evaluate its role in reducing norepinephrine requirements and reducing incidence of post-induction hypotension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients with American Society of Anaesthesiologists (ASA) Grading I E to III E.
- •2.Patients scheduled for emergency laparotomy under General Anaesthesia.
排除标准
- •Patients with a history of difficult intubation, abnormal airway examination, cardiac morbidities.
- •Patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications
- •Patients with uncontrolled hypertension.
- •Patients with existing hypotension on inotrope support.
- •Patients with allergy of any of the study drugs.
结局指标
主要结局
Comparison between 1:1 and 1:3 ratios of ketamine-propofol admixture with requirement of norepinephrine.
时间窗: First 20 minutes after induction of anaesthesia
次要结局
- To assess and compare the incidence and severity of post induction hypotension.(First 20 minutes after induction of anaesthesia)
- To assess and compare the intubation conditions using intubation scoring.(First 20 minutes after induction of anaesthesia)
研究者
Dr M Pradeep
MS Ramaiah Medical College
