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Lignocaine Nebulization for Attenuation of Intubation Stress Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441073
Recruitment Status : Not yet recruiting
First Posted : June 22, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
FATMA NABIL AHMED MOHAMED, 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

Condition or disease Intervention/treatment Phase
Pressor Response Drug: Lignocaine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lignocaine Nebulization for Attenuation of Intubation Stress Response in Patients With Severe Pre-eclampsia: a Prospective Double-blinded Placebo-controlled Trial
Estimated Study Start Date : June 24, 2020
Estimated Primary Completion Date : June 23, 2021
Estimated Study Completion Date : July 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lignocaine
preoperative nebulization of lignocaine
Drug: Lignocaine
preoperative nebulization of lignocaine

Placebo Comparator: Placebo
preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
Drug: Placebo
preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
Other Name: Normal saline (Nacl 0.9%)




Primary Outcome Measures :
  1. Systolic, diastolic, mean arterial blood pressure [ Time Frame: Preoperative-Intraoperative ]
  2. Heart rate [ Time Frame: Preoperative-Intraoperative ]
  3. Peripheral oxygen saturation [ Time Frame: Preoperative-Intraoperative ]
  4. Cough score during emergence [ Time Frame: 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 :
  1. APGAR score [ Time Frame: 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


  2. Sore throat and hoarseness of voice [ Time Frame: Postoperative (one, 6 and 24 hours) ]
    The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441073


Contacts
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Contact: Fatma N. Mohamed, M.D. +201003633992 fatmanabil2012@gmail.com
Contact: Alaa A. Gharib, M.B.B.Ch. lola.gh2022@gmail.com

Locations
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Egypt
Assiut University
Assiut, Egypt, 71515
Contact: Fatma N. Mohamed, M.D.    +201003633992    fatmanabil2012@gmail.com   
Contact: Alaa Gharib       lola.gh2022@gmail.com   
Sponsors and Collaborators
Assiut University
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Responsible Party: FATMA NABIL AHMED MOHAMED, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04441073    
Other Study ID Numbers: Lignocaine nebulization stress
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FATMA NABIL AHMED MOHAMED, Assiut University:
pressor response
pre-eclampsia
Lignocaine
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action