Dexmedetomidine for Attenuation of Pressor Response

NCT ID: NCT06592027

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-05-30

Brief Summary

Direct laryngoscopy and tracheal intubation are usually associated by hemodynamic changes due to increased sympathoadrenal activity which could precipitate serious negative effects in compromised patients . The pressor response could be blunted by dexmedetomidine which is a selective alpha 2 agonist which might provide hemodynamic stability during tracheal intubation.

Detailed Description

Various drugs include local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics have been tried to blunt the laryngoscopy and intubation response, with varied success. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its various effects have led to its increasing use for reducing anesthetic and analgesic requirements in the perioperative period. It inhibits sympathetic activity thus terminating the pain signals and thereby blunts the pressor response associated with laryngoscopy and endotracheal intubation. Electrical cardiometry is recently introduced for assessment of many cardiovascular variables and continuously applicable method of cardiac output (CO), stroke volume (SV), and other hemodynamic parameters monitoring. Its use is growing because it is non-invasive, shows reliability in CO measurements and can be used as a continuous bedside monitor Although different doses of dexmedetomidine (0.5- 2.0 μg/kg) have been used in various studies which suggested its efficacy in blunting the hemodynamic pressor response , However, no studies to the best of our knowledge had incorporated CO monitoring for detection of minimal hemodynamic changes during laryngoscopy and endotracheal intubation which can be best achieved by using Cardiometry monitor.

In this study, we will compare two doses of dexmedetomidine for prophylaxis against pressor response of ETI using cardiometry.

Conditions

Pressor Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

this group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion

Group Type: PLACEBO_COMPARATOR

PRECEDEX INJ★ 2ML

Intervention Type: DRUG

this group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion

Group B

this group will receive single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion

Group Type: ACTIVE_COMPARATOR

PRECEDEX INJ★ 2ML

Intervention Type: DRUG

single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion

Interventions

PRECEDEX INJ★ 2ML

this group will receive single dose of dexmedetomidine 0.5 mcg /kg in 50 ml normal saline over 10 min IV infusion

Intervention Type: DRUG

PRECEDEX INJ★ 2ML

single dose of dexmedetomidine 1 mcg /kg in 50 ml normal saline over 10 min IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1 - ASA physical status 1-2. 2. Age 18- 60 years old of both sexes. 3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.

Exclusion Criteria

1. Age < 18 years and ≥ 60 years

2. Pregnancy

3. Emergency surgery or full stomach

4. Renal or Hepatic patients

5. Patients with suspected difficult airway {e.g., high neck circumference, high body mass index (above 30 kg/m2), airway masses, mouth scars, neck scars, limited neck extension or history of snoring.

6. Total duration of laryngoscopy will be noted and in cases where duration exceeded 15 sec the case will be excluded from the study.

7. Any patient on regular intake of beta blockers or calcium channel blockers

8. Patients with any known hypersensitivity or contraindication to dexmedetomidine,

9. Patients with significant neurological, psychiatric, or neuromuscular disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Moshira sayed mohamed

Lecturer of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moshira Sayed Lecturer of anesthesia and intensive care, M.D.

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Research Institute

Locations

Theodor Bilharz Research institute

Giza, , Egypt

Countries

Egypt

References

Misra S, Behera BK, Mitra JK, Sahoo AK, Jena SS, Srinivasan A. Effect of preoperative dexmedetomidine nebulization on the hemodynamic response to laryngoscopy and intubation: a randomized control trial. Korean J Anesthesiol. 2021 Apr;74(2):150-157. doi: 10.4097/kja.20153. Epub 2020 May 20.

Reference Type: BACKGROUND

PMID: 32434291 (View on PubMed)

Other Identifiers

PT (811)

Identifier Type: -

Identifier Source: org_study_id