NCT06712186

Brief Summary

Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to provide several benefits during endotracheal intubation:

  1. 1.\_Reduced anxiety and stress\_: Dexmedetomidine's anxiolytic and sedative effects help reduce anxiety and stress associated with endotracheal intubation.
  2. 2.\_Improved intubating conditions\_: Dexmedetomidine can improve intubating conditions by reducing the incidence of coughing, bucking, and laryngospasm.
  3. 3.\_Decreased hemodynamic responses\_: Dexmedetomidine can attenuate the hemodynamic responses to intubation, including tachycardia, hypertension, and increased cardiac output.
  4. 4.\_Increased ease of intubation\_: Dexmedetomidine can facilitate smoother and easier intubation by reducing the need for additional anesthetics or muscle relaxants.
  5. 5.\_Decreased heart rate\_: Dexmedetomidine can cause a decrease in heart rate due to its effects on the sympathetic nervous system.
  6. 6.\_Decreased blood pressure\_: Dexmedetomidine can also cause a decrease in blood pressure due to its vasodilatory effects.
  7. 7.\_Increased sedation\_: Dexmedetomidine's sedative effects can help reduce anxiety and stress during intubation.
  8. 8.\_Reduced respiratory rate\_: Dexmedetomidine can cause a decrease in respiratory rate due to its effects on the respiratory centers in the brain.
  9. 9.\_Improved patient comfort\_: Dexmedetomidine's sedative and anxiolytic effects can improve patient comfort during intubation.
  10. 10.\_Reduced need for additional anesthetics\_: Dexmedetomidine can reduce the need for additional anesthetics or muscle relaxants during intubation.
  11. 11.\_Decreased risk of complications\_: Dexmedetomidine's effects on hemodynamic responses and respiratory rate can decrease the risk of complications during intubation.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

June 22, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

November 25, 2024

Last Update Submit

December 6, 2024

Conditions

Elective Surgical PatientHypertensive PatientsBlood PressureHypertensive Elderly PatientsAnxiolytic

Keywords

LaryngoscopyDexmedetomidineHemodynamic ResponseEndotracheal intubationPressor responseHypertensionIntubationGeneral anesthesiaa 2 agonistSedativeAnxiolytic

Outcome Measures

Primary Outcomes (1)

  • Mean Arterial Pressure (MAP)

    The primary outcome is to measure the change in Mean Arterial Pressure before endotracheal intubation and 5 minutes after intubation. An increase or decrease in MAP of 20 mmHg of patient's baseline MAP within 5 minutes of endotracheal intubation will be considered significant in our study. The focus is on whether Dexmedetomidine maintain MAP with 20mmhg of patient's baseline reading.

    At 5 minutes after laryngoscopy and endotracheal intubation.

Secondary Outcomes (2)

  • Heart Rate (HR)

    Baseline & 5 minutes

  • Blood pressure (BP)

    Baseline & 5 minutes

Study Arms (2)

Intervention group/Group D

EXPERIMENTAL

Intervention group: Group D patients will be administer 0.5 mcg/kg dexmedetomidine intravenously over 10 min preoperatively.

Drug: Dexmedetomidine Group / Group D

Control group/Group C

PLACEBO COMPARATOR

Control group: Group C patients will be administer the same volume of normal saline (also intravenously for 10 min)

Other: Normal Saline (Placebo)

Interventions

Dexmedetomidine Group / Group DDRUG

In this study, the intervention involve administrating 0.5 mcg/kg of Inj dexmedetomidine intravenously over 10 min to patients in intervention group/group D 2 minutes prior to Endotracheal intubation using laryngoscopy aiming to asses its efficacy in attenuating the pressor response to laryngoscopy.

Also known as: Dexemeditomidine
Intervention group/Group D
Normal Saline (Placebo)OTHER

The Placebo group / group C will be administer Normal Saline without any active medication over 10 min to patients, 2 minutes prior to Endotracheal intubation using laryngoscopy to compare its effect to those of Dexmedetomidine in attenuating the pressor response to laryngoscopy.

Also known as: normal saline
Control group/Group C

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Grade II
  • Age \> 60 years
  • Elective surgical procedures under GA.
  • All patients with a diagnosis of hypertension for 6 months or more and undergoing treatment with antihypertensive medications.

You may not qualify if:

  • Patient refusal
  • ASA Grade III and IV
  • Severely Hypovolemic state
  • Emergency surgeries
  • Body weight more than 20% of ideal body weight.
  • Patients with known or unanticipated difficult intubation and those requiring more than 15 sec or two attempts at laryngoscopy
  • Allergic to dexmedetomidine
  • Non complaint hypertensive patients
  • Patients with uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital and Medical College

Karachi, Sindh, Pakistan

RECRUITING

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Warisha ismail Dr Warisha ismail

    Liaquat National Hospital and Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Warisha Ismail Dr Warisha Ismail

CONTACT

+92 3046878028khanveera97@gmail.com

Ghulam fatima Ghulam Fatima

CONTACT

+92336873293drghulamfatimakhar@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Warisha Ismail Dr, FCPS I

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 2, 2024

Study Start

June 22, 2024

Primary Completion

November 22, 2024

Study Completion

December 1, 2024

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

\*Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns. Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. IPD may require additional validation and quality control checks before sharing, which can be time-consuming and resource-intensive.

Locations

PA(1)