Lignocaine Nebulization for Attenuation of Intubation Stress Response

Phase 4

• Conditions: Pressor Response
• Interventions: Drug: Placebo; Drug: Lignocaine

• Registration Number: NCT04441073
• Lead Sponsor: Assiut University

Brief 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

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 Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Study Start: 2021-02-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-16
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
Lignocaine	Lignocaine	preoperative nebulization of lignocaine

Primary Outcome Measures

Name	Time	Method
Systolic, diastolic, mean arterial blood pressure	Preoperative-Intraoperative
Heart rate	Preoperative-Intraoperative
Peripheral oxygen saturation	Preoperative-Intraoperative
Cough score during emergence	Up to one hour after extubation	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)

Secondary Outcome Measures

Name	Time	Method
APGAR score	One, 5 and 10 minutes after delivery of the fetus	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
Sore throat and hoarseness of voice	Postoperative (one, 6 and 24 hours)	The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt