A Prospective Randomised Study to Evaluate the Efficacy of Two Different Doses of Intranasal Nitroglycerine Spray in Attenuating Haemodynamic Stress Response to Pneumoperitoneum during Laparoscopic Surgeries
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Outcome Measure: Change in haemodynamic parameters – Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) – from baseline following induction of anaesthesia and during pneumoperitoneum.
研究概览
简要总结
Brief Summary
Laparoscopic surgeries require creation of pneumoperitoneum, which frequently produces sympathetic stimulation leading to tachycardia, hypertension, and increased myocardial oxygen demand. Such haemodynamic stress responses may be detrimental, especially in high-risk patients. Nitroglycerine, a nitric oxide donor and vasodilator, has a rapid onset of action when administered intranasally and may blunt these responses effectively.
The present prospective, randomised study is designed to evaluate the efficacy of two different doses of intranasal nitroglycerine spray in attenuating the haemodynamic stress response to pneumoperitoneum during laparoscopic surgeries under general anaesthesia. Patients will be randomised into two groups to receive one of the two test doses prior to pneumoperitoneum. Haemodynamic parameters including heart rate, systolic, diastolic and mean arterial pressures will be recorded at defined time-points and compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •all adult patients of either 18 to 65 years Here a suitable Inclusion Criteria section for my trial in CTRI formet Inclusion Criteria
- •Adult patients aged 18 to 65 years.
- •ASA Physical Status I–II.
- •Scheduled for elective laparoscopic abdominal surgery ( cholecystectomy appendicectomy diagnostic laparoscopy) under general anaesthesia.
- •Duration of surgery expected to be less than 2 hours.
- •Ability to provide written informed consent.
排除标准
- •patient refusal patient with known allergies to study medication patient with uncontrolled hypertension perioperative bradycardia (heart and renal disease) patient on chronic opioid or alpha2-adrenergic agonist or antagonist therapy pregnant or lactating.
结局指标
主要结局
Outcome Measure: Change in haemodynamic parameters – Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) – from baseline following induction of anaesthesia and during pneumoperitoneum.
时间窗: From baseline (pre-induction) up to 15 minutes after creation of pneumoperitoneum.
次要结局
未报告次要终点
研究者
DR Maina Singh
Department of anesthesiology in jln medical College ajmer rajasthan