Hemodynamic Responses to Laryngoscopy and Tracheal Intubation

Effectiveness of Intravenous Ketodex Versus Ketofol for Obtunding Hemodynamic Responses to Laryngoscopy and Tracheal Intubation in Adult Elective Middle Ear Surgery Patients: A Prospective Randomized Comparative Study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07783256

Enrollment

Registered

2026-08-24

Start date

2026-12-20

Completion date

2028-12-20

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Response to Laryngoscopy and Tracheal Intubation

Brief summary

Laryngoscopy and tracheal intubation lead to tachycardia and hypertension due to increase in the plasma catecholamines subsequent to sympathetic stimulation.

Detailed description

Various prophylactic interventions have been tried to blunt the hemodynamic stress response to laryngoscopy and tracheal intubation. The ketamine-dexmedetomidine combination (ketodex) and ketamine-propofol combination (ketofol) may be of benefit in maintaining hemodynamic stability and reducing potential side effects of each drug.

Interventions

DRUGketodex

Patients will receive a single IV bolus dose of both ketamine and dexmedetomidine

DRUGketofol

Patients will receive a single IV bolus dose of both ketamine and propofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Adult patients scheduled for elective middle ear surgery under general anesthesia, ASA status I-II, aged from 18 to 60 years old of either sex.

Exclusion criteria

* Full stomach or emergency surgery * Any known contraindications or allergy to ketamine, dexmedetomidine, or propofol * Pregnancy or breastfeeding women * Body mass index (BMI) \> 35 Kg/m2 * History of hepatic, renal, or cardiac disease * Patients in whom the duration of laryngoscopy will last more than 25 seconds * Chronic opioid use, or history of neuropsychiatric disorders * Patient refusal

Design outcomes

Primary

Measure	Time frame	Description
Heart rate accompanying laryngoscopy and tracheal intubation with cuff inflation	The fifth minute after laryngoscopy and tracheal intubation with cuff inflation	Assessed in beats per minute

Contacts

CONTACTSeham M Moeen, M.D.

seham.moeen@aun.edu.eg01006386324

CONTACTMohammed F Aly

rescu2016@aun.edu.eg01002610390

PRINCIPAL_INVESTIGATORSeham M Moeen, M.D.

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026