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

NCT04622202 | Unknown Phase 1

• 1 other identifier: 6408
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety State; Sedation

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• Number of participant with changes in level of consciousness

  at 60 minutes preoperative

• Heart rate

  at 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.

• Serum glucose

  preoperative and at 10 minutes after intubation.

• cortisol level

  preoperative and at 10 minutes after intubation.

Study Arms (2)

pregabalin

ACTIVE COMPARATOR

oral capsule pregabalin 150 mg.

Drug: Pregabalin 150mg

multivitamin

PLACEBO COMPARATOR

oral multivitamin capsule.

Drug: multivitamin

Interventions

Pregabalin 150mg DRUG

oral capsule pregabalin 150 mg.

Also known as: Lyrica

pregabalin

multivitamin DRUG

oral placebo in the form of oral multivitamin capsule.

Also known as: Placebo

multivitamin

Eligibility Criteria

• Age: 21 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Sara Mohamed Abdel Nabi

Zagazig, 002055, Egypt

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Pregabalin; Geritol

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sara Abdel Naby, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Abdel Naby, M.D

CONTACT

01096017090; sara.abdelnaby.ali@gmail.com

Alshaimaa kamel, M.D

CONTACT

01005593169; AlshaimaaKamel80@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia and surgical intensive care

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 9, 2020
• Study Start: November 15, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 1, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

EG (1)