Lignocaine Nebulization for Attenuation of Intubation Stress Response

Study Overview
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Brief Summary
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To study the effect of lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia

Detailed Description
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The pressor response to laryngoscopy and tracheal intubation is a very important issue in hypertensive pregnant patients that can lead to increased maternal intracranial pressure, cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal mortality. The catecholamine release associated with laryngoscopy and intubation also causes uteroplacental vasoconstriction and adversely affect the neonate well-being. Therefore, the precise control of stress is necessary during general anesthesia in pre-eclamptic patients.Various drugs are used to suppress the pressor response including opioids, lidocaine, along with α and β adrenergic blockers. in this study the investigators will evaluate the effect of lignocaine nebulization on attenuation of the pressor response.

Official Title
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Lignocaine Nebulization for Attenuation of Intubation Stress Response in Patients With Severe Pre-eclampsia: a Prospective Double-blinded Placebo-controlled Trial

Conditions
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Pressor Response

Intervention / Treatment
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* Drug: Lignocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia Scheduled for caesarean deliveries under general anesthesia Exclusion Criteria: severe obesity (BMI ≥ 40 ) Cardiac patients History of diabetes Renal dysfunction (Elevated creatinine ≥ 2 mg\dl) Hepatic dysfunction (Elevated hepatic enzymes three times above normal value) Known fetal anomalies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lignocaine<br>preoperative nebulization of lignocaine | Drug: Lignocaine<br>* preoperative nebulization of lignocaine<br>|
| Placebo Comparator: Placebo<br>preoperative nebulization of normal saline (Nacl 0.9%) as a placebo | Drug: Placebo<br>* preoperative nebulization of normal saline (Nacl 0.9%) as a placebo<br>* Other names: Normal saline (Nacl 0.9%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic, diastolic, mean arterial blood pressure |  | Preoperative-Intraoperative | 
| Heart rate |  | Preoperative-Intraoperative | 
| Peripheral oxygen saturation |  | Preoperative-Intraoperative | 
| Cough score during emergence | Grade of coughing (grade 0: no cough; grade 1: single cough with mild severity; grade 2: cough lasting less than 5 seconds with moderate severity; grade 3: more than 5 seconds of persistent cough) | Up to one hour after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR score | APGAR stands for Appearance, Pulse, Grimace, Activity, and Respiration. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score | One, 5 and 10 minutes after delivery of the fetus | 
| Sore throat and hoarseness of voice | The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions | Postoperative (one, 6 and 24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressor response, pre-eclampsia, Lignocaine