Comparitive study on the effect of nebulised ropivacaine with or without dexmedetomine on hemodynamic response during intubation in surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To compare the effects on hemodynamic response with
研究概览
简要总结
The larynx is a structure richly innervated with abundant neurovascular supply. In general
anaesthesia, while laryngoscopy and endotracheal intubation is done, it triggers significant
hemodynamic response which is pressor response. This can lead to hypertension and tachycardia.
This is due to activation of somatovisceral reflex. Sympatho adrenal stimulus leads to the
release of catecholamines which results in increase in hemodynamics. This can cause
potential complications like cardiac ischaemia, irregular heart rhythm, cerebral bleed etc.
Duration and intensity of intubation directly affects the body catecholamine response
typically begins within 5 to 10s and peeks at 1 to 2 mins and returns to baseline within 5 mins.
These are tolerated by healthy individuals and can cause complications in susceptible
patients.
Ropivacaine is a long-acting amide local anaesthetic has its ability to block nociceptive
stimuli at peripheral nerves. Using Ropivacaine as a local anaesthetic during intubation can
help mitigate hemodynamic fluctuations and cough response during extubation due to its
longer duration of action.
Dexmedetomidine is a highly selective centrally acting alpha 2 agonist with sedative,
anxiolytic, hypnotic, perioperative sympatholytic, and anaesthetic sparing effects that reduce
central sympathetic outflow and attenuate the stress response associated with surgery
providing good perioperative hemodynamic stability. Its commonly associated with systemic
side effects such as hypotension, bradycardia.
Nebulization offers increased bioavailability. 65 percent nasal mucosa absorption and 82 percent via
buccal mucosa absorption. Nebulized Dexmedetomidine has a short half life of 6 mins and
elimination half life of 2hrs without being associated with systemic side effects.
In the present study, our primary aim is to evaluate and compare the hemodynamic response
during intubation following the pre treatment with nebulised Ropivacaine alone versus a
combination of nebulised Ropivacaine and Dexmedetomidine.
In the present study we hypothesise that combining Dexmedetomidine and Ropivacaine
results in a more effective suppression of the pressor response than using Ropivacaine by
itself.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anaesthesiologists ASA physical status 1 and 2 patients undergoing elective surgeries under general anesthesia.
排除标准
- •American society of Anaesthesiologists ASA physical status III/IV.
- •Hemodynamically unstable.
- •h/o recent sore throat / URTI/ LRTI.
- •h/o allergy to Ropivacaine.
- •h/o allergy to Dexmedetomidine.
- •patients with cardiac, renal, liver disorders.
- •anticipated difficult airway.
结局指标
主要结局
To compare the effects on hemodynamic response with
时间窗: Hemodynamic parameters (HR, SBP, DBP, and MAP) will be | monitored and recorded at 1, 3, 5, 10, and 15 minutes following intubation.
nebulised Ropivacaine with or without Dexmedetomidine during intubation in patients
时间窗: Hemodynamic parameters (HR, SBP, DBP, and MAP) will be | monitored and recorded at 1, 3, 5, 10, and 15 minutes following intubation.
undergoing surgery under general anaesthesia.
时间窗: Hemodynamic parameters (HR, SBP, DBP, and MAP) will be | monitored and recorded at 1, 3, 5, 10, and 15 minutes following intubation.
次要结局
- Post operative incidence of sore throat(- Post operative sedation score)
研究者
Dr Shubhadha D Amin
M S Ramaiah Medical College