Lignocaine Nebulization for Attenuation of Intubation Stress Response

Pressor Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441073
• Other study ID #: Lignocaine nebulization stress
• Status: Recruiting
• Phase: Phase 4
• Start date: February 24, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Fatma N. Mohamed, M.D.
• Phone: +201003633992
• Email: fatmanabil2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Pressor Response

Intervention

Drug:
• Lignocaine
preoperative nebulization of lignocaine
• Placebo
preoperative nebulization of normal saline (Nacl 0.9%) as a placebo

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic, diastolic, mean arterial blood pressure		Preoperative-Intraoperative
Primary	Heart rate		Preoperative-Intraoperative
Primary	Peripheral oxygen saturation		Preoperative-Intraoperative
Primary	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	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
Secondary	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)