Comparison of neuromuscular blocking characteristics of Cisatracurium with and without its priming dose in elderly patients undergoing general anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to onset of neuromuscular block.
研究概览
简要总结
AIM
To compare neuromuscular blocking characteristics of cisatracurium with and without its priming dose in elderly patients undergoing General Anaesthesia.
PRIMARY OBJECTIVE :- To compare the effect on time of onset of action of cisatracurium given with and without its priming dose in elderly patients undergoing General Anaesthesia.
SECONDARY OBJECTIVES :-
1.) To compare the effect on the time to complete block of cisatracurium given with and without its priming dose in elderly patients undergoing General Anaesthesia.
2.) To compare hemodynamic parameters and side effect profile in patients of two groups.
METHOD OF RANDOMIZATION
60 ASA grade I and II patients will be divided into two groups 1 and 2 by using computer generated random number table.
GROUP 1 (n= 30) : Patients will receive Priming Dose of Inj. Cisatracurium at dose of 0.015 mg/kg. GROUP 2 (n=30) : Patients will receive Normal Saline 5 ml.
METHOD OF PREPARING PRIMING DOSE :-
Group 1 (n=30) will receive priming dose of injection cisatracurium IV (dose as per weight) & will dilute it with Normal Saline to make 5 ml.
Group 2 (n=30) will receive Normal Saline 5 ml.
METHOD OF GIVING GENERAL ANESTHESIA
A preanesthetic evaluation will be done for all the cases.
Written and Informed Consent will be taken.
All patients will be kept fasting for 8 hours night before surgery.
In OT , multipara monitors will be attached to record ECG, Non-invasive blood pressure (NIBP), SpO2 , End-tidal Carbon dioxide (Et CO2) and temperature.
Baseline parameters will be recorded for all patients.
IV access will be established.
Neuromuscular monitoring apparatus will be attached to the patient.
NMT apparatus will be set to TOF with supramaximal stimulus at 0.05 Hz and frequency at 20 seconds.
Patient will be pre-oxygenated with 100% O2 for 3 minutes using appropriate size face mask. Patients will receive Inj. Midazolam 0.03 mg/ kg IV, Inj. Fentanyl 2 mcg /kg IV
Priming dose will be given in group 1 as 0.015 mg/kg in Normal Saline to make 5 ml solution and 5 ml Normal Saline only will be given in group 2.
We will wait for 3 minutes after giving priming dose and before starting induction of anaesthesia.
METHOD OF ONSET OF ACTION :
Time of onset will be noted when TOF count is 2/4
METHOD OF KNOWING COMPLETE BLOCK :
Time to complete block will be noted when TOF count is 0/4
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 65.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI 18-30, ASA grade 1&2, Modified Mallampati grade 1&2.
排除标准
- •Patients with anticipated difficult airway, uncontrolled DM, uncontrolled hypertension, untreated CAD, post CVA, extremes of weight, uncontrolled asthma, neuromuscular disorders, history of atopy, active copd, patients on antibiotics, known history of allergy to Cisatracurium.
结局指标
主要结局
Time to onset of neuromuscular block.
时间窗: Time at which TOF count is 2/4
次要结局
- Time to complete block.(Time at which TOF count is 4/4)