跳至主要内容
临床试验/CTRI/2022/09/045555
CTRI/2022/09/045555尚未招募不适用

A comparative study between intravenous lignocaine versus intravenous magnesium sulphate for attenuation ofhaemodynamic stress response during laryngoscopy and tracheal intubation in abdominal surgeries.

RAMAKRISHNA MISSION SEVA PRATISHTHAN1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年9月20日最近更新:

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)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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