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

Phase 1

• Conditions: Sedation; Anxiety State
• Interventions: Drug: Pregabalin 150mg; Drug: multivitamin

• Registration Number: NCT04622202
• Lead Sponsor: Zagazig University

Brief 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

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-09
• Study Start: 2020-11-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-02-28
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregabalin	Pregabalin 150mg	oral capsule pregabalin 150 mg.
multivitamin	multivitamin	oral multivitamin capsule.

Primary Outcome Measures

Name	Time	Method
preoperative maternal anxiety changes	change from baseline at 60 minutes after giving drug preoperative.	Anxiety by State-Trait Anxiety Inventory (STAI) questionnaire before drug administration and 60 minutes after giving drug (pre-induction).

Secondary Outcome Measures

Name	Time	Method
Serum glucose	preoperative and at 10 minutes after intubation.	Serum glucose level will be recorded preoperative and at 10 minutes after intubation.
Number of participant with changes in level of consciousness	at 60 minutes preoperative	changes in level of consciousness of participant by Alert, verbal response, pain response and unresponsive (AVPU) scale 60 minutes after giving drug (pre-induction).; Alert: The patient is aware of the examiner and can respond to the environment around them on their own. The patient can also follow commands, open their eyes spontaneously, and track objects.; Verbally Responsive: The patient's eyes do not open spontaneously. The patient's eyes open only in response to a verbal stimulus directed toward them. The patient is able to react to that verbal stimulus directly and in a meaningful way.; Painfully Responsive: The patient's eyes do not open spontaneously. The patient will only respond to the application of painful stimuli by an examiner. The patient may move, moan, or cry out directly in response to the painful stimuli.; Unresponsive: The patient does not respond spontaneously. The patient does not respond to verbal or painful stimuli.
Heart rate	at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.	Heart rate will be recorded preoperative baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
cortisol level	preoperative and at 10 minutes after intubation.	cortisol level will be recorded preoperative and at 10 minutes after intubation.
Baby Apgar score	at 1 and 5 minutes after delivery	Apgar score at 1 and 5 min after delivery Apgar Scoring; Apgar Sign 2 1 0 Appearance (skin color) Normal color all over (hands and feet are pink) Normal color (but hands and feet are bluish) Bluish-gray or pale all over Pulse (heart rate) Normal (above 100 beats per minute) Below 100 beats per minute Absent (no pulse) Grimace ("reflex irritability") Pulls away, sneezes, coughs, or cries with stimulation Facial movement only (grimace) with stimulation Absent (no response to stimulation) Activity (muscle tone) Active, spontaneous movement Arms and legs flexed with little movement No movement, "floppy" tone Respiration (breathing rate and effort) Normal rate and effort, good cry Slow or irregular breathing, weak cry Absent (no breathing); A baby who scores a 7 or above on the test is considered in good health.
mean arterial blood pressure	at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.	mean arterial blood pressure

Trial Locations

Locations (1)

Sara Mohamed Abdel Nabi; 🇪🇬 Zagazig, Egypt