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

Procedural Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04873596
• Other study ID #: 6869
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Zagazig University
• Contact: Alshaimaa Kamel, M.D
• Phone: 01005593169
• Email: AlshaimaaKamel80[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Procedural Sedation

Intervention

Drug:
• Nebulized dexmedetomidine
parturient will receive nebulized 3ug/kg dexmedetomidine.
• Nebulized midazolam
parturient will receive nebulized 0.2 mg/kg midazolam.

Locations

Country	Name	City	State
Egypt	Zagazig University, Faculty of medicine	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Heart rate	heart rate in beat/ minute	Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Secondary	Mean arterial blood pressure	Mean arterial blood pressure in mmHg	Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.
Secondary	Oxygen saturation	Oxygen saturation by pulse oximetry.	Baseline, at 0 minute (after nebulization), 5 minutes then every 10 minutes intraoperative.