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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04441073
Enrollment
100
Registered
2020-06-22
Start date
2021-02-24
Completion date
2022-02-23
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressor Response

Keywords

pressor response, pre-eclampsia, Lignocaine

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.

Interventions

preoperative nebulization of lignocaine

DRUGPlacebo

preoperative nebulization of normal saline (Nacl 0.9%) as a placebo

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic, diastolic, mean arterial blood pressurePreoperative-Intraoperative
Heart ratePreoperative-Intraoperative
Peripheral oxygen saturationPreoperative-Intraoperative
Cough score during emergenceUp to one hour after extubationGrade 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

MeasureTime frameDescription
APGAR scoreOne, 5 and 10 minutes after delivery of the fetusAPGAR 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 voicePostoperative (one, 6 and 24 hours)The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions

Countries

Egypt

Contacts

Primary ContactFatma N. Mohamed, M.D.
fatmanabil2012@gmail.com+201003633992
Backup ContactAlaa A. Gharib, M.B.B.Ch.
lola.gh2022@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026