Lignocaine Nebulization for Attenuation of Intubation Stress Response

NCT04441073 | Unknown Phase 4

• 1 other identifier: Lignocaine nebulization stress
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pressor Response

Keywords

pressor response; pre-eclampsia; Lignocaine

Outcome Measures

Primary Outcomes (4)

• Systolic, diastolic, mean arterial blood pressure

  Preoperative-Intraoperative

• Heart rate

  Preoperative-Intraoperative

• Peripheral oxygen saturation

  Preoperative-Intraoperative

• 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)

  Up to one hour after extubation

Secondary Outcomes (2)

• APGAR score

  One, 5 and 10 minutes after delivery of the fetus

• Sore throat and hoarseness of voice

  Postoperative (one, 6 and 24 hours)

Study Arms (2)

Lignocaine

EXPERIMENTAL

preoperative nebulization of lignocaine

Drug: Lignocaine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lignocaine DRUG

preoperative nebulization of lignocaine

Lignocaine

Placebo DRUG

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

Also known as: Normal saline (Nacl 0.9%)

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia
• Scheduled for caesarean deliveries under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Lidocaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Fatma N. Mohamed, M.D.

CONTACT

+201003633992; fatmanabil2012@gmail.com

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

CONTACT

lola.gh2022@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 22, 2020
• Study Start: February 24, 2021
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

EG (1)