A Phase 1/2 interventional study of Pregabalin 150mg and multivitamin in Anxiety State and Sedation, sponsored by Zagazig University. Status unknown at 1 site in Egypt. Open to female participants aged 21 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Zagazig University · Phase 1/2, Interventional, and Treatment
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
4,874 studies on the registry are indexed under Anxiety Disorders; 1,394 are open to participants now.
This study's planned enrollment of 74 is close to the median of 80 across 4,180 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
oral capsule pregabalin 150 mg.
Drug: Pregabalin 150mg
oral multivitamin capsule.
Drug: multivitamin
oral capsule pregabalin 150 mg.
Also known as: Lyrica
oral placebo in the form of oral multivitamin capsule.
Also known as: Placebo
preoperative maternal anxiety changes
Anxiety by State-Trait Anxiety Inventory (STAI) questionnaire before drug administration and 60 minutes after giving drug (pre-induction).
Time frame: change from baseline at 60 minutes after giving drug preoperative.
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.
Time frame: 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.
Time frame: at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
mean arterial blood pressure
mean arterial blood pressure
Time frame: 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.
Time frame: preoperative and at 10 minutes after intubation.
cortisol level
cortisol level will be recorded preoperative and at 10 minutes after intubation.
Time frame: 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.
Time frame: at 1 and 5 minutes after delivery
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zagazig University