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

Zagazig University94 enrolled

Overview

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

Site of study: This study will be carried out in operating theater of obstetrics at Zagazig University Hospitals. Withdrawal Criteria: The woman has the right to withdraw from the study at any time without any negative consequence on their medical or surgical treatment plan. Double -blind randomized clinical trial. All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every woman.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Procedural Sedation

Interventions

Nebulized dexmedetomidineDRUG

parturient will receive nebulized 3ug/kg dexmedetomidine.

Nebulized midazolamDRUG

parturient will receive nebulized 0.2 mg/kg midazolam.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 38 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Zagazig University, Faculty of medicine

Zagazig, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

The discharge time from Post Anesthesia Care Unite (PACU) in minutes when achieving modified Aldrete Score 9. Modified Aldert Score. Activity, able to move, voluntarily or on command 4 extremities = 2 2 extremities = 1 No = 0 Breathing Able to breathe deeply \& cough freely= 2 Dyspnea, shallow or limited breathing =1 Apnea= 0 Consciousness Fully awake = 2 Arousable on calling = 1 Unresponsive = 0 Circulation (BP) ±20% of pre-anesthesia level= 2 * 20% to 49% of pre-anesthesia level= 1 * 50% of pre-anesthesia level= 0 SPO2 Maintains SpO2 \>92% in ambient air= 2 Maintain SpO2 \>90% with O2 = 1 Maintain SpO2 \<90% with O2 = 0

Time frame: up to 30 minutes postoperative

Maternal satisfaction with procedure

Maternal satisfaction with procedure using a 5-point numerical rating scale. 0= Extremely dissatisfied 1. Dissatisfied 2. Neutral 3. Satisfied 4. Extremely satisfied

Time frame: up to 24hour postoperative

APGAR score

APGAR score at 1 and 5 min after delivery APGAR score (13). Indicator Score 0 Score 1 Score 2 Activity (muscle tone) Limp; no movement Some flexion of arms and legs Active motion Pulse (heart rate) No heart rate Fewer than 100 beats per minute At least 100 beats per minute Grimace (reflex response) No response to airways being suctioned Grimace during suctioning Grimace and pull away, cough, or sneeze during suctioning Appearance (color) The baby's whole body is completely bluish-gray or pale Good color in body with bluish hands or feet Good color all over Respiration (breathing) Not breathing Weak cry; may sound like whimpering, slow or irregular breathing Good, strong cry; normal rate and effort of breathing Total Score: 3 and below require immediate resuscitation 4 to 7 may require resuscitative measures 7 to 10 is considered normal

Central Contacts

Alshaimaa Kamel, M.D

CONTACT

01005593169 AlshaimaaKamel80@yahoo.com

Dina Abdelhameed Elsadek salem, M.D

CONTACT

01099333513 dinamagapy@yahoo.com

Data from ClinicalTrials.gov

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