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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04441073
Other study ID # Lignocaine nebulization stress
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
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