Anxiety StatePhase 1/2NCT04622202
Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
A Phase 1/2 study testing Pregabalin 150mg and multivitamin in people with Anxiety State and Sedation, run by Zagazig University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 21 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Sedation
- What is being tested?
- Pregabalin 150mg and multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2020to 1 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sara Mohamed Abdel Nabi
Zagazig, 002055
Sara M Abdel Nabi, M.D, Sara.abdelnaby.ali@gmail.com
Alshaimaa Kamel, M.D, 01128595629 ext. Abdel Nabi, Sara.abdelnaby.ali@gmail.com
About this study
Official title: 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
Read the 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
- Conditions
- Anxiety State, Sedation
- Being tested
- Pregabalin 150mg, multivitamin
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
Also called Lyrica
oral capsule pregabalin 150 mg.
multivitaminDrug
Also called Placebo
oral placebo in the form of oral multivitamin capsule.
| Study group | Role | What they receive |
|---|---|---|
| pregabalin | Active comparator | oral capsule pregabalin 150 mg. Receives: Drug: Pregabalin 150mg |
| multivitamin | Placebo comparator | oral multivitamin capsule. Receives: Drug: multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative maternal anxiety changes
Anxiety by State-Trait Anxiety Inventory (STAI) questionnaire before drug administration and 60 minutes after giving drug (pre-induction).
Measured: change from baseline at 60 minutes after giving drug preoperative.
Secondary outcomes (6)
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.
Measured: 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.
Measured: at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
mean arterial blood pressure
mean arterial blood pressure
Measured: 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.
Measured: preoperative and at 10 minutes after intubation.
cortisol level
cortisol level will be recorded preoperative and at 10 minutes after intubation.
Measured: 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.
Measured: at 1 and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start15 Nov 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sara mohamed Abdelnaby, Zagazig University
- Investigators
- Sara Abdel Naby, M.D, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622202
- Sponsor's protocol ID
- 6408
- Status last verified
- Feb 2021
- First submitted
- 27 Oct 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Pre-emptive Single Oral Dose Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
- ClinicalTrials.gov ID
- NCT04622202
- Acronym / sponsor ID
- 6408
- Conditions
- Anxiety State, Sedation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregabalin | Active comparator | Drug: Pregabalin 150mgoral capsule pregabalin 150 mg. |
| multivitamin | Placebo comparator | Drug: multivitaminoral multivitamin capsule. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 150mgAlso: Lyricaoral capsule pregabalin 150 mg. | Drug | pregabalin |
| multivitaminAlso: Placebooral placebo in the form of oral multivitamin capsule. | Drug | multivitamin |
Primary outcome
preoperative maternal anxiety changes
Time frame: 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).
6 secondary outcomes
Number of participant with changes in level of consciousness
Time frame: at 60 minutes preoperative
Heart rate
Time frame: at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
mean arterial blood pressure
Time frame: at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
Serum glucose
Time frame: preoperative and at 10 minutes after intubation.
cortisol level
Time frame: preoperative and at 10 minutes after intubation.
Baby Apgar score
Time frame: at 1 and 5 minutes after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Abdel Naby, M.D principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pregabalin 150mg and multivitamin in people with Anxiety State and Sedation, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Abdel Naby, M.D (01096017090 ext. 002, sara.abdelnaby.ali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preoperative maternal anxiety changes (time frame: change from baseline at 60 minutes after giving drug preoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.