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

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622202
• Other study ID #: 6408
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 15, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2021
• Source: Zagazig University
• Contact: Sara Abdel Naby, M.D
• Phone: 01096017090
• Email: sara.abdelnaby.ali[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: March 1, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Sedation

Intervention

Drug:
• Pregabalin 150mg
oral capsule pregabalin 150 mg.
• multivitamin
oral placebo in the form of oral multivitamin capsule.

Locations

Country	Name	City	State
Egypt	Sara Mohamed Abdel Nabi	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preoperative maternal anxiety changes	Anxiety by State-Trait Anxiety Inventory (STAI) questionnaire before drug administration and 60 minutes after giving drug (pre-induction).	change from baseline at 60 minutes after giving drug preoperative.
Secondary	Number of participant with changes in level of consciousness	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.	at 60 minutes preoperative
Secondary	Heart rate	Heart rate will be recorded preoperative baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.	at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
Secondary	mean arterial blood pressure	mean arterial blood pressure	at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
Secondary	Serum glucose	Serum glucose level will be recorded preoperative and at 10 minutes after intubation.	preoperative and at 10 minutes after intubation.
Secondary	cortisol level	cortisol level will be recorded preoperative and at 10 minutes after intubation.	preoperative and at 10 minutes after intubation.
Secondary	Baby Apgar score	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.	at 1 and 5 minutes after delivery