Lignocaine Nebulization for Attenuation of Intubation Stress Response

NCT ID: NCT04441073

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2022-02-23

Brief Summary

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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

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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.

Conditions

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Pressor Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lignocaine

preoperative nebulization of lignocaine

Group Type EXPERIMENTAL

Lignocaine

Intervention Type DRUG

preoperative nebulization of lignocaine

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Lignocaine

preoperative nebulization of lignocaine

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Normal saline (Nacl 0.9%)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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FATMA NABIL AHMED MOHAMED

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Fatma N. Mohamed, M.D.

Role: CONTACT

+201003633992

Alaa A. Gharib, M.B.B.Ch.

Role: CONTACT

Facility Contacts

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Fatma N. Mohamed, M.D.

Role: primary

+201003633992

Alaa Gharib

Role: backup

Other Identifiers

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Lignocaine nebulization stress

Identifier Type: -

Identifier Source: org_study_id

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