NCT07164326

Brief Summary

Dexmedetomidine nebulization in sever preeclamptic patients

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

August 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 30, 2025

Last Update Submit

September 6, 2025

Conditions

Keywords

PreeclampsiaNebulization

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure in response to endotracheal intubation

    the change in systolic blood pressure in response to endotracheal intubation

    Intraoperative

Secondary Outcomes (3)

  • Optic nerve sheath diameter

    Intraoperative

  • Incidence of maternal postoperative sore throat

    1 hour Postoperative

  • Incidence of maternal postoperative hoarseness of voice

    1 hour Postoperative

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Nebulization of dexmedetomidine

Drug: Dexmedetomidine

Saline

PLACEBO COMPARATOR

Nebulization of saline

Drug: Saline

Interventions

Nebulization of dexmedetomidine

Dexmedetomidine
SalineDRUG

Nebulization of normal saline

Saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

DexmedetomidineSodium Chloride

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Mohamed S. Hussein

CONTACT

Fatma Nabil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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.

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 10, 2025

Study Start

October 15, 2025

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

September 10, 2025

Record last verified: 2025-08