Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia

NCT04873596 | Recruiting Phase 2

• 1 other identifier: 6869
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Null hypothesis: There is no difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal Anesthesia in pre-eclamptic parturients Alternative hypothesis: There is difference between the effects of nebulization of dexmedetomidine and midazolam as procedural sedation during cesarean delivery under spinal anesthesia in pre-eclamptic parturients

Conditions

Procedural Sedation

Outcome Measures

Primary Outcomes (1)

• Chane in the level of sedation

  Change in the level of sedation will be assessed using Ramasy Sedation Assessment Scale Ramsay Sedation Scale 1= Patient is anxious and agitated or restless, or both 3= Patient responds to commands only 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6= Patient exhibits no response

  at 0 minute (immediately after nebulization) , 5 minutes then every 15 minutes intraoperative

Secondary Outcomes (6)

• The discharge time from Post Anesthesia Care Unite (PACU) .

  up to 30 minutes postoperative

• Maternal satisfaction with procedure

  up to 24hour postoperative

• APGAR score

  at 1 and 5 min after delivery

• Heart rate

  Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.

• Mean arterial blood pressure

  Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.

Study Arms (2)

nebulized dexmedetomidine

ACTIVE COMPARATOR

parturient will receive nebulized 3ug/kg dexmedetomidine diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.

Drug: Nebulized dexmedetomidine

nebulized midazolam

ACTIVE COMPARATOR

parturient will receive nebulized 0.2 mg/kg midazolam diluted in normal saline (0.9%) solution till total volume of nebulized solution will become 5 ml and will be nebulized by a standard hospital jet nebulizer via mouthpiece, with a continuous flow of 100% oxygen at 6 L/min. for 15 minutes, and the treatment will be stopped when the nebulizer will be began to sputter.

Drug: Nebulized midazolam

Interventions

Nebulized dexmedetomidine DRUG

parturient will receive nebulized 3ug/kg dexmedetomidine.

Also known as: precedex

nebulized dexmedetomidine

Nebulized midazolam DRUG

parturient will receive nebulized 0.2 mg/kg midazolam.

Also known as: Dormicum

nebulized midazolam

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.
• Mild and moderate preeclampsia parturient.
• American Society of AnesthesiologistPhysical status II.
• Body Mass Index (BMI) (25-35kg/m²).
• Type of operations: elective cesarean section under spinal anesthesia.
• Written informed consent from the parturient.

You may not qualify if:

• Altered mental state.
• Women with known history of allergy to study drugs.
• Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, advanced hepatic, renal, cardiovascular, respiratory disease and neuropsychiatric disorders.
• Patients receiving anticonvulsants or antidepressants.
• Sever preeclampsia, intrauterine growth restriction or fetal compromise.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of medicine

Zagazig, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alshaimaa Kamel, M.D

  Zagazig University, Faculty of human medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alshaimaa Kamel, M.D

CONTACT

01005593169; AlshaimaaKamel80@yahoo.com

Dina Abdelhameed Elsadek salem, M.D

CONTACT

01099333513; dinamagapy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 5, 2021
• Study Start: May 15, 2021
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

EG (1)