NCT04622202

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

The Effects Of Pre-emptive Single Oral Dose Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: Female
• Age: 21 Years – 38 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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

Conditions

• Anxiety State
• Sedation

Interventions

Type	Name	Description
DRUG	Pregabalin 150mg	oral capsule pregabalin 150 mg.
DRUG	multivitamin	oral placebo in the form of oral multivitamin capsule.

Timeline

• Start date: 2020-11-15
• Primary completion: 2021-02-28
• Completion: 2021-03-01
• First posted: 2020-11-09
• Last updated: 2021-02-04

Locations

1 site across 1 country: Egypt