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

Comparison Between Dexmedetomidine and Midazolam Nebulization as Procedural Sedation During Cesarean Delivery Under Spinal Anesthesia in Pre-eclamptic Parturients

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

Study Overview

• Status: Recruiting
• Conditions: Procedural Sedation
• Intervention / Treatment: Drug: Nebulized dexmedetomidine; Drug: Nebulized midazolam

Detailed Description

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
• Enrollment (Estimated): 94
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dina Abdelhameed Elsadek salem, M.D; Phone Number: 002 01099333513; Email: dinamagapy@yahoo.com
• Study Contact Backup: Name: Alshaimaa Kamel, M.D; Phone Number: 002 01005593169; Email: AlshaimaaKamel80@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt
    • Recruiting
    • Zagazig University, Faculty of medicine
    • Contact: Alshaimaa Kamel, M.D; Phone Number: 002 01005593169; Email: AlshaimaaKamel80@yahoo.com
    • Principal Investigator: Alshaimaa Kamel, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nebulized dexmedetomidine; 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; parturient will receive nebulized 3ug/kg dexmedetomidine.; Other Names: precedex
Active Comparator: nebulized midazolam; 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; parturient will receive nebulized 0.2 mg/kg midazolam.; Other Names: Dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 30 minutes postoperative
Maternal satisfaction with procedure	Maternal satisfaction with procedure using a 5-point numerical rating scale. 0= Extremely dissatisfied; Dissatisfied; Neutral; Satisfied; Extremely satisfied	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	at 1 and 5 min after delivery
Heart rate	heart rate in beat/ minute	Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Mean arterial blood pressure	Mean arterial blood pressure in mmHg	Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Oxygen saturation	Oxygen saturation by pulse oximetry.	Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Alshaimaa Kamel, M.D, Zagazig University, Faculty of human medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 6869 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No