Comparative study of effect of intravenous magnesium sulphate and fentanyl on hemodynamic responses to nasal intubation and laryngoscopy in oral cancer patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Intravenous magnesium sulphate will be more effective than fentanyl in providing sustained attenuation of hemodynamic responses (heart rate and blood pressure) during nasal intubation in oral cancer patients.
研究概览
简要总结
This prospective, randomized study at Acharya Vinoba Bhave Rural Hospital (2024–2027) compares IV magnesium sulphate (30 mg/kg) and fentanyl (2 mcg/kg) for controlling heart rate and blood pressure during nasal intubation in oral cancer patients. Sixty-four patients are randomized into two groups. Both groups receive standardized anesthesia and peri-induction drugs. Hemodynamic parameters, number of intubation attempts, interventions for instability, and adverse events are systematically documented. The study aims to determine which drug provides superior, sustained blunting of cardiovascular responses, with findings expected to guide safer anesthesia practices and future research on optimal agents for high-risk airway management
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 25 to 60 years.
- •Diagnosed with oral cancer requiring elective surgery under general Anaesthesia with nasal intubation.
- •ASA Physical Status: Classified as ASA III Informed Consent: written informed consent, in the case of minors or those unable to consent, consent obtained from their legal guardians.
- •General Health: Patients with no contraindications for either magnesium sulphate or fentanyl administration.
- •Planned Surgery: Patients scheduled for elective oral cancer surgery.
排除标准
- •Renal Impairment: Patients with renal insufficiency or chronic kidney disease (CKD), as magnesium sulphate may cause toxicity in those with impaired renal function.
- •Respiratory Conditions: Patients with severe chronic obstructive pulmonary disease (COPD), asthma, or other significant pulmonary diseases Neurological Disorders: Patients with neuromuscular disorders (e.g., myasthenia gravis) that may be exacerbated by the NMDA receptor antagonist properties of magnesium sulphate.
- •Allergic Reactions: Patients with a known allergy or hypersensitivity to magnesium sulphate, fentanyl, or any other opioids.
- •Pregnancy or Lactation: or breastfeeding women.
结局指标
主要结局
Intravenous magnesium sulphate will be more effective than fentanyl in providing sustained attenuation of hemodynamic responses (heart rate and blood pressure) during nasal intubation in oral cancer patients.
时间窗: 15 minutes
次要结局
- 1)To determine the duration of hemodynamic control offered by each drug following intubation.(2)To assess the need for additional pharmacological intervention in either group to maintain hemodynamic stability during or after intubation.)
研究者
Rahul Gattani
Datta Meghe Institute Of Medical Science And Research