Dexmedetomidine for Attenuation of Pressor Response

NCT06592027 | Completed Phase 4 DMC

• 1 other identifier: PT (811)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressor Response

Keywords

Dexmedetomidine; pressor response; optimum dose

Outcome Measures

Primary Outcomes (1)

• Heart rate measurment

  single measurement after intubation

  after 1 minute of successful tracheal intubation

Secondary Outcomes (1)

• cardiac output

  from the start of induction of anesthesia till 5 minutes after successful tracheal intubation

Study Arms (2)

Group A

PLACEBO COMPARATOR

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

Drug: PRECEDEX INJ★ 2ML

Group B

ACTIVE COMPARATOR

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

Drug: PRECEDEX INJ★ 2ML

Interventions

PRECEDEX INJ★ 2ML DRUG

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

Group A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years and ≥ 60 years
• Pregnancy
• Emergency surgery or full stomach
• Renal or Hepatic patients
• 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.
• Total duration of laryngoscopy will be noted and in cases where duration exceeded 15 sec the case will be excluded from the study.
• Any patient on regular intake of beta blockers or calcium channel blockers
• Patients with any known hypersensitivity or contraindication to dexmedetomidine,
• Patients with significant neurological, psychiatric, or neuromuscular disorders.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research institute

Giza, 02, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32434291 BACKGROUND

Study Officials

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

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: Lecturer of anesthesia and intensive care

Model Details: The aim of our study is to assess and compare the efficacy of two different doses of dexmedetomidine (0.5 μg/kg and 1.0 μg/ kg) to find out its optimal dose in attenuation of hemodynamic pressor response to laryngoscopy and intubation with the use of Cardiometry for continuous CO monitoring beat by beat.

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)