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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety State; Sedation
• Intervention / Treatment: Drug: Pregabalin 150mg; Drug: multivitamin

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 Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sara Abdel Naby, M.D; Phone Number: 002 01096017090; Email: sara.abdelnaby.ali@gmail.com

Study Locations

• Egypt
  • Zagazig, Egypt, 002055
    • Recruiting
    • Sara Mohamed Abdel Nabi
    • Contact: Sara M Abdel Nabi, M.D; Email: Sara.abdelnaby.ali@gmail.com
    • Contact: Alshaimaa Kamel, M.D; Phone Number: Abdel Nabi 01128595629; Email: Sara.abdelnaby.ali@gmail.com
    • Principal Investigator: Sara M Abdel Nabi, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pregabalin; oral capsule pregabalin 150 mg.	Drug: Pregabalin 150mg; oral capsule pregabalin 150 mg.; Other Names: Lyrica
Placebo Comparator: multivitamin; oral multivitamin capsule.	Drug: multivitamin; oral placebo in the form of oral multivitamin capsule.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
mean arterial blood pressure	mean arterial blood pressure	at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
Serum glucose	Serum glucose level will be recorded preoperative and at 10 minutes after intubation.	preoperative and at 10 minutes after intubation.
cortisol level	cortisol level will be recorded preoperative and at 10 minutes after intubation.	preoperative and at 10 minutes after intubation.
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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Sara Abdel Naby, M.D, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: 6408

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No