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Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section

Primary Purpose

Anxiety State, Sedation

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin 150mg
multivitamin
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety State

Eligibility Criteria

21 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sara Mohamed Abdel NabiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

pregabalin

multivitamin

Arm Description

oral capsule pregabalin 150 mg.

oral multivitamin capsule.

Outcomes

Primary Outcome Measures

preoperative maternal anxiety changes
Anxiety by State-Trait Anxiety Inventory (STAI) questionnaire before drug administration and 60 minutes after giving drug (pre-induction).

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2020
Last Updated
February 1, 2021
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04622202
Brief Title
Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
Official Title
The Effects Of Pre-emptive Single Oral Dose Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State, Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Active Comparator
Arm Description
oral capsule pregabalin 150 mg.
Arm Title
multivitamin
Arm Type
Placebo Comparator
Arm Description
oral multivitamin capsule.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Other Intervention Name(s)
Lyrica
Intervention Description
oral capsule pregabalin 150 mg.
Intervention Type
Drug
Intervention Name(s)
multivitamin
Other Intervention Name(s)
Placebo
Intervention Description
oral placebo in the form of oral multivitamin capsule.
Primary Outcome Measure Information:
Title
preoperative maternal anxiety changes
Description
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.
Secondary Outcome Measure Information:
Title
Number of participant with changes in level of consciousness
Description
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
Title
Heart rate
Description
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.
Title
mean arterial blood pressure
Description
mean arterial blood pressure
Time Frame
at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
Title
Serum glucose
Description
Serum glucose level will be recorded preoperative and at 10 minutes after intubation.
Time Frame
preoperative and at 10 minutes after intubation.
Title
cortisol level
Description
cortisol level will be recorded preoperative and at 10 minutes after intubation.
Time Frame
preoperative and at 10 minutes after intubation.
Title
Baby Apgar score
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Abdel Naby, M.D
Phone
01096017090
Ext
002
Email
sara.abdelnaby.ali@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alshaimaa kamel, M.D
Phone
01005593169
Ext
002
Email
AlshaimaaKamel80@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Abdel Naby, M.D
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sara Mohamed Abdel Nabi
City
Zagazig
ZIP/Postal Code
002055
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara M Abdel Nabi, M.D
Email
Sara.abdelnaby.ali@gmail.com
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, M.D
Phone
01128595629
Ext
Abdel Nabi
Email
Sara.abdelnaby.ali@gmail.com
First Name & Middle Initial & Last Name & Degree
Sara M Abdel Nabi, M.D

12. IPD Sharing Statement

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Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section

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