Dexmedetomidine Nebulization for Attenuation of Pressor R... | NCT07164326

Studies
Dexmedetomidine Nebulization for Attenuation of Pressor Response to Laryngoscopy and Endotracheal Intubation in Sever Preeclamptic Patients

NCT07164326

Sponsor

Assiut University

Status

Not yet recruiting

Last Update Posted

Sep 10, 2025Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Pressor Response

Interventions

Dexmedetomidine
Saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2025Estimated

Primary Completion Date

Nov 15, 2026Estimated

Completion Date

Dec 15, 2026Estimated

First Submitted Date

Aug 30, 2025

First Submission Date that Met QC Criteria

Sep 6, 2025

First Posted Date

Sep 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2025

Last Update Posted Date

Sep 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Sayed Hussein Hassan, Dexmedetomidine nebulization for attenuation of pressor response to laryngoscopy and endotracheal intubation in sever preeclamptic patients undergoing caesarean section under general anaesthesia. A prospective randomized clinical trial., Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dexmedetomidine nebulization in sever preeclamptic patients

Detailed Description

Dexmedetomidine nebulization for attenuation of pressor response to laryngoscopy and endotracheal intubation in sever preeclamptic patients undergoing caesarean section under general anaesthesia. A prospective randomized clinical trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine	Experimental	Nebulization of dexmedetomidine	Drug: Dexmedetomidine
Saline	Placebo Comparator	Nebulization of saline	Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Nebulization of dexmedetomidine	Dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic blood pressure in response to endotracheal intubation	the change in systolic blood pressure in response to endotracheal intubation	Intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Optic nerve sheath diameter	the change in optic nerve sheath diameter in response to endotracheal intubation	Intraoperative
Incidence of maternal postoperative sore throat		1 hour Postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with severe pre-eclampsia scheduled for cesarean section under general anesthesia
ASA II, III

Exclusion Criteria:

sever obesity (BMI ≥ 40)
Cardiac patients
History of diabetes mellitus
Renal dysfunction (elevated serum creatinine > 2mg\dl)
hepatic dysfunction (elevated hepatic enzyme three times above normal)
History to hypersensitivity to the tested drug.
Emergency surgery
Known fetal anomalies

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed S. Hussein	Contact	+201028586836		mohamedmsh4274@gmail.com
Fatma Nabil	Contact			fatmanabil2012@aun.edu.eg

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided