Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section

Zagazig University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Sedation; Anxiety State

Treatments: Drug: Pregabalin 150mg; Drug: multivitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT04622202

6408

Details and patient eligibility

About

There is exaggerated neuroendocrine stress response to laryngoscopy and endotracheal intubation during the Induction to anesthesia-delivery (I-D) period under light anesthesia. Mechanical stimulation of laryngeal proprioceptors elicits increased secretion of cortisol and catecholamine with subsequent elevation of blood pressure from 40 to 50 % and heart rate up to 20 % during direct laryngoscopy and endotracheal intubation

Full description

The sample size was calculated using OPEN EPI program assuming that the mean visual analogue scale anxiety score was 49.3±14.1 among oral pregabalin group and was 58.6± 14.4 among Placebo group (8) so at power of study 80% confidence interval 95%, the sample size was calculated to be 74 cases (37in each group

Enrollment: 74 estimated patients

Sex: Female

Ages: 21 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 21-38 years old.
• Pregnant Female with a singleton fetus of at least 36 weeks of gestation.
• American Society of Anesthesiologist Physical status: 1& II.
• Body Mass Index (BMI) (25-30kg/m²).
• Type of operations: elective caesarean section under general anesthesia.
• Written informed consent from the parturient.

Exclusion criteria

• Altered mental state.
• Women with known history of allergy to pregabalin.
• Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, Hepatic, renal, Cardiovascular, respiratory disease and neuropsychiatric disorders.
• Patients receiving anticonvulsants, antidepressants.
• Pregnancy induced hypertension, intrauterine growth restriction or fetal compromise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

pregabalin

Active Comparator group

Description:

oral capsule pregabalin 150 mg.

Treatment:

Drug: Pregabalin 150mg

multivitamin

Placebo Comparator group

Description:

oral multivitamin capsule.

Treatment:

Drug: multivitamin