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临床试验/CTRI/2024/03/064545
CTRI/2024/03/064545尚未招募2 期

TO STUDY THE EFFICACY OF INTRAVENOUS MAGNESIUM SULPHATE WITH AND WITHOUT LIGNOCAINE SPRAY IN ATTENTUATING THE PRESSOR RESPONSE TO LARYNGOSCOPY AND INTUBATION

Mahatma Gandhi medical college1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
To assess and compare the Heart rate and blood pressure variation due to pressor response between the two study groups.

研究概览

简要总结

Depending on the study drug to be administered, the chosen patients will be randomized into 2 Groups, ML and M by computer generated randomization using sealedenvelope.com. Concealment will be done using sealed envelope technique. Group ML will receive intravenous MgSO4 (30 mg/kg) and 10% lignocaine spray; Group M will get intravenous MgSO4 (30 mg/kg).

All patients will be pre-medicated with tab. Alprazolam 0.5 mg oral, the night before surgery and a minimum fasting state of six hours before anaesthesia will be ensured in all patients. On arrival in the operating room, standard monitoring such as electrocardiography, pulse oximetry (SpO2), non-invasive blood pressure monitoring will be connected to the patient and the baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded.

Prior to induction, pre-medications such as inj. Midazolam 0.05 mg/kg IV and inj. Morphine 0.1 mg/kg IV will be given, and all patients will be preoxygenated with 100% oxygen for three minutes. Prior to induction, both the groups will receive intravenous magnesium sulphate 30mg/kg as slow iv over two minutes. Induction will be carried out with injection propofol till the loss of verbal response. Muscle relaxation will be achieved with inj. vecuronium 0.1mg/kg after assessing adequacy of mask ventilation.  Positive pressure mask ventilation will be provided to ensure adequate oxygenation and ventilation. Three minutes after giving vecuronium, laryngoscopy will be done, following which group ML patients will receive 10% Lignocaine spray. Positive pressure mask ventilation will be provided for two minutes after which laryngoscopy and tracheal intubation will be done. In group M, after administration of vecuronium, positive pressure mask ventilation will be done for three minutes. Then, laryngoscopy will be done followed by endotracheal intubation. An experienced anaesthesiologist will perform the laryngoscopy, and a suitable-sized cuffed endotracheal tube will be used for orotracheal intubation. Only patients whose intubation will be performed in a single try within 20 seconds and using a standard McIntosh curved blade laryngoscope will be included in the study. After intubation, surgical stimulation will not be allowed for 10 minutes. Maintenance of general anaesthesia, intraoperative monitoring and reversal of neuro-muscular blockade and extubation following the standard practice.

Parameters like Heart Rate (HR); systolic blood pressure (SBP); diastolic blood pressure (DBP); mean arterial pressure (MAP) will be recorded at Baseline; after administration of the study drug; after administration of propofol; at laryngoscopy with spraying, immediately after intubation; at two, four, six, eight and at 10 minutes after induction. Patients will be carefully monitored for any complications including hypotension and bradycardia which will be managed by Inj. Mephentermine and Inj. Atropine accordingly.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • patients belonging to ASA grade I, II.
  • Patients posted for surgery under general anaesthesia
  • 18-60 years of age
  • Male and Female.

排除标准

  • history of allergic to local anaesthetic agents Patients with coronary artery disease Difficult airway hypertensive patients on two or more medications BMI greater than 30.

结局指标

主要结局

To assess and compare the Heart rate and blood pressure variation due to pressor response between the two study groups.

时间窗: To assess baseline heart rate and blood pressure and the variations after the administration of the test drug, during intubation, 2 minutes, 4 minutes, 6 minutes, 8 minutes and at 10 minutes after intubation.

次要结局

  • To assess sedation score post extubation using Ramsay sedation scale between the two groups.(to be assessed before shifting the patient to recovery room.)

研究者

发起方
Mahatma Gandhi medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Harini P

Mahatma Gandhi medical college, Pondicherry

研究点 (1)

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