NCT03204006

Brief Summary

Attenuation of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation With Single Dose of Dexmedetomidine in Hypertensive Patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

April 7, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

June 26, 2017

Last Update Submit

April 5, 2020

Conditions

Stress Response During Laryngoscopy Intubation

Outcome Measures

Primary Outcomes (1)

  • heart rate

    through first 15 min post-induction of anesthesia

Secondary Outcomes (2)

  • systolic blood pressure

    through first 15 min post-induction of anesthesia

  • diastolic blood pressure

    through first 15 min post-induction of anesthesia

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

35 patients will receive dexmedetomidine 0.5 µg/kg was administered intravenously using a syringe pump over 10 min sterile saline pre-induction of anesthesia.

Drug: Dexmedetomidine

Control group

PLACEBO COMPARATOR

35 patients will receive sterile saline 0.5 µg/kg was administered intravenously using a syringe pump over 10 min pre-induction of anesthesia.

Drug: sterile saline

Interventions

DexmedetomidineDRUG

Dexmedetomidine preinduction

Dexmedetomidine group
sterile salineDRUG

normal saline preinduction

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Age group 20-60 years
  • ASA grade 1 and 2
  • control hypertensive patients.

You may not qualify if:

  • \- Consent not given
  • ASA Grade 3 and 4
  • history of myocardial ischemia or infarction, or had an abnormal ECG on admission to the hospital
  • Patients with cardiovascular, pulmonary, hepatic, and renal disease.
  • Patients on B blockers.
  • patients with difficult airway; laryngoscopy and intubation time more than 20 s, or requiring more than two attempts will be exclude from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 29, 2017

Study Start

March 8, 2018

Primary Completion

March 8, 2020

Study Completion

March 12, 2020

Last Updated

April 7, 2020

Record last verified: 2020-03

Locations

EG(1)