Anxiety State, Sedation
Conditions
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
Interventions
DRUGPregabalin 150mg
oral capsule pregabalin 150 mg.
DRUGmultivitamin
oral placebo in the form of oral multivitamin capsule.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 38 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| mean arterial blood pressure | at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation. | mean arterial blood pressure |
| Serum glucose | preoperative and at 10 minutes after intubation. | Serum glucose level will be recorded preoperative and at 10 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. |
| 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. |
Countries
Egypt
Contacts
Primary ContactSara Abdel Naby, M.D
Backup ContactAlshaimaa kamel, M.D
Outcome results
None listed