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Lignocaine Nebulization for Attenuation of Intubation Stress Response

A

Assiut University

Status and phase

Unknown
Phase 4

Conditions

Pressor Response

Treatments

Drug: Lignocaine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04441073
Lignocaine nebulization stress

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Lignocaine
Experimental group
Description:
preoperative nebulization of lignocaine
Treatment:
Drug: Lignocaine
Placebo
Placebo Comparator group
Description:
preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Fatma N. Mohamed, M.D.; Alaa A. Gharib, M.B.B.Ch.

Data sourced from clinicaltrials.gov

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