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Lignocaine Nebulization for Attenuation of Intubation Stress Response

Primary Purpose

Pressor Response

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Lignocaine

Placebo

About this trial

This is an interventional prevention trial for Pressor Response focused on measuring pressor response, pre-eclampsia, Lignocaine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Assiut UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lignocaine

Placebo

Arm Description

preoperative nebulization of lignocaine

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

Outcomes

Primary Outcome Measures

Systolic, diastolic, mean arterial blood pressure

Heart rate

Peripheral oxygen saturation

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)

Secondary Outcome Measures

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

Sore throat and hoarseness of voice

The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions

Full Information

NCT ID

NCT04441073

First Posted

June 5, 2020

Last Updated

January 16, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT04441073

Brief Title

Lignocaine Nebulization for Attenuation of Intubation Stress Response

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2021 (Actual)

Primary Completion Date

February 23, 2022 (Anticipated)

Study Completion Date

February 23, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressor Response

Keywords

pressor response, pre-eclampsia, Lignocaine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lignocaine

Arm Type

Experimental

Arm Description

preoperative nebulization of lignocaine

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lignocaine

Intervention Description

preoperative nebulization of lignocaine

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal saline (Nacl 0.9%)

Intervention Description

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

Primary Outcome Measure Information:

Title

Systolic, diastolic, mean arterial blood pressure

Time Frame

Preoperative-Intraoperative

Title

Heart rate

Time Frame

Preoperative-Intraoperative

Title

Peripheral oxygen saturation

Time Frame

Preoperative-Intraoperative

Title

Cough score during emergence

Description

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)

Time Frame

Up to one hour after extubation

Secondary Outcome Measure Information:

Title

APGAR score

Description

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

Time Frame

One, 5 and 10 minutes after delivery of the fetus

Title

Sore throat and hoarseness of voice

Description

The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions

Time Frame

Postoperative (one, 6 and 24 hours)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fatma N. Mohamed, M.D.

Phone

+201003633992

fatmanabil2012@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

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

lola.gh2022@gmail.com

Facility Information:

Facility Name

Assiut University

City

Assiut

ZIP/Postal Code

71515

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fatma N. Mohamed, M.D.

Phone

+201003633992

fatmanabil2012@gmail.com

First Name & Middle Initial & Last Name & Degree

Alaa Gharib

lola.gh2022@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Lignocaine Nebulization for Attenuation of Intubation Stress Response

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