A comparative study between intravenous lignocaine versus intravenous magnesium sulphate for attenuation ofhaemodynamic stress response during laryngoscopy and tracheal intubation in abdominal surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Comparison of attenuation of haemodynamic response during induction of general anesthesia between intravenous magnesium sulphate and lignocaine to compare:
研究概览
简要总结
A total 120 patients will be enrolled for the study after obtaining a written consent
from these patients. These patients will be randomly allocated by rapid sampling into
2 groups of 60 patients each by using computer generated random number table. Two
types of coloured balls Red and Yellow would be given to each patient when allocated
initially for the study. The patient can pick up any ball at their own discretion.
 Group A –Red ball – Allocated for iv Lignocaine
Group B –Yellow ball – Allocated for iv Magnesium sulphate
ï‚· Group A will receive 2%Lignocaine(without preservative) 1.5 mg/kg IV bolus given over
1 min before induction. Group B will receive 50% Magnesium sulphate 30 mg/kg
diluted and made upto 20 ml IV bolus with normal saline, IV bolus over 3 minutes
before induction of anaesthesia.
ï‚· Pre-anesthetic evaluation will be done day before OT. All patients will be on NPO for
solid food for 8 hours, for light meal up to 6 hours, for non clear fluid up to 4 hours
and for clear fluids up to 2 hours before the anaesthesia.
 In the operation theater, the patient’s body weight, fasting status, consent, and preanaesthetic
check up will be checked, i.v cannula will be established. Standard
monitors like ECG, Pulse oximeter, NIBP will be connected to the patients and baseline
heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean
arterial blood pressure (MAP), Rate Pressure Product (RPP) will be noted.
ï‚· Rate pressure product will be calculated from recordings of SBP and HR (formula: SBP
x HR), which will be recorded at various time intervals. The RPP is an index of
myocardial oxygen demand.
ï‚· All patients will be premedicated by midazolam 0.2 mg/kg IV and patients according
to their respective group will receive (without preservative) Lignocaine or Magnesium
sulphate and hemodynamic parameters will be recorded after 10 minutes from the
time of administration of the Lignocaine or Magnesium sulphate. Then after 10
minutes of initiation of infusion of (without preservative) Lignocaine or Magnesium
sulphate, general anaesthesia will be induced by IV Fentanyl 1-1.5 μg/kg, Propofol 1-
2 mg/kg. After achieving proper mask ventilation Atracurium 0.5 mg/kg will be given
16
to facilitate tracheal intubation. Then the patient will be mask ventilated for 3 minutes
followed by laryngoscopy and endotracheal intubation; then Atracurium 0.1 mg/kg
will be given as maintenance at regular intervals.
ï‚· According to patient haemodynamics, anaesthesia will be maintained with Nitrous
oxide 60%, Isoflurane 0.6-1.0% in 40% oxygen. The lungs will be mechanically
ventilated and the end-tidal carbon dioxide concentration will be maintained at 30-40
mm Hg. No surgical or any other stimulus will be applied during 10 minutes of study
period.
ï‚· Hemodynamic parameters including HR, SBP, DBP, MAP, RPP and any adverse effect
will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
At the end of the surgery, neuromuscular block will be reversed with Neostigmine at
a dosage 0.05 mg/kg iv and Glycopyrrolate at a dose of 0.004 mg/kg/iv dose.
ï‚· Premedication with iv Lignocaine or iv Magnesium sulphate before induction of
general anesthesia during Laryngoscopy and Tracheal intubation helps in attenuation
of haemodynamic stress response and have no as such side effects per say, both these
drugs can be used interchangeably without affecting the safety of the patients.
ï‚·
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant 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
- •a Patients posted for surgeries under general anaesthesia b Patients with ASA Class I and II.
排除标准
- •a Known allergy to anaesthetic agents b History of a major psychiatric disorder c History of substance abuse and current opioid use d Anticipated difficult intubation e Patients on beta blockers f Baseline systolic blood pressure (SBP) less than 100 mm Hg g Compensatory Tachycardia h Pregnancy i Diabetic Patients j Hypertensive patients on medication.
结局指标
主要结局
Comparison of attenuation of haemodynamic response during induction of general anesthesia between intravenous magnesium sulphate and lignocaine to compare:
时间窗: will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
DBP
时间窗: will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
HR
时间窗: will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
Any adverse drug reaction
时间窗: will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
SBP
时间窗: will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
次要结局
- Comparison of attenuation of haemodynamic response including,MAP & RPP during induction of general anesthesia between intravenous magnesium sulphate and lignocaine(Hemodynamic parameters including MAP & RPP and any adverse effect)
