Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Active Comparator | oral capsule pregabalin 150 mg. |
|
| multivitamin | Placebo Comparator | oral multivitamin capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 150mg | Drug | oral capsule pregabalin 150 mg. |
|
|
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Abdel Naby, M.D | Contact | 01096017090 | 002 | sara.abdelnaby.ali@gmail.com |
| Alshaimaa kamel, M.D | Contact | 01005593169 | 002 | AlshaimaaKamel80@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Sara Abdel Naby, M.D | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sara Mohamed Abdel Nabi | Recruiting | Zagazig | 002055 | Egypt |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| multivitamin | Drug | oral placebo in the form of oral multivitamin capsule. |
|
|
| 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 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |