Lignocaine Nebulization for Attenuation of Intubation Stress Response

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

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

Study Overview

• Status: Recruiting
• Conditions: Pressor Response
• Intervention / Treatment: Drug: Lignocaine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fatma N. Mohamed, M.D.; Phone Number: +201003633992; Email: fatmanabil2012@gmail.com
• Study Contact Backup: Name: Alaa A. Gharib, M.B.B.Ch.; Email: lola.gh2022@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University
    • Contact: Fatma N. Mohamed, M.D.; Phone Number: +201003633992; Email: fatmanabil2012@gmail.com
    • Contact: Alaa Gharib; Email: lola.gh2022@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lignocaine; preoperative nebulization of lignocaine	Drug: Lignocaine; preoperative nebulization of lignocaine
Placebo Comparator: Placebo; preoperative nebulization of normal saline (Nacl 0.9%) as a placebo	Drug: Placebo; preoperative nebulization of normal saline (Nacl 0.9%) as a placebo; Other Names: Normal saline (Nacl 0.9%)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Anticipated): February 23, 2022
• Study Completion (Anticipated): February 23, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: pre-eclampsia; Lignocaine; pressor response
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Lignocaine nebulization stress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No