Dexmedetomidine Versus Dexmedetomidine and Ketamine (Ketodex) in Ear and Nose Surgeries

NCT ID: NCT06981494

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2025-12-10

Brief Summary

The study aims to compare the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.

• Assessment the analgesic and sedative role of both drugs.

Detailed Description

Comparison regarding the efficacy, safety and overall effectiveness of dexmedetomidine and dexmedtomidine and ketamine (ketodex) in achieving controlled hypotension during Ear and nose surgeries.

• comparison between both drugs in recovery and hemodynamics stability
• Assessment the analgesic and sedative role of both drugs

Conditions

Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine Group (D)

Dexmedetomidine Group (D) :

We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine

Loading Dose:

Dexmedetomidine is usually administered as a loading dose of 0.5 mcg/kg slowly.

Maintenance Dose:

After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Loading Dose:

Dexmedetomidine is usually administered as a loading dose of 0.25 mcg/kg slowly.

Maintenance Dose:

After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.

Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):

Ketamine Component:

We give intravenous the loading and maintenance dose of the general anaesthesia drug Dexmedetomidine and ketamine

Loading Dose:

Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection.

Maintenance Dose:

A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.

Dexmedetomidine Component:

Loading Dose:

As with the dexmedetomidine group, a loading dose of 0.5 mcg/kg slowly is administered.

Maintenance Dose:

The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine and ketamine ( Ketodex )

Intervention Type: DRUG

Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):

Ketamine Component:

Loading Dose:

Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection.

Maintenance Dose:

A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.

Dexmedetomidine Component:

Loading Dose:

As with the dexmedetomidine group, a loading dose of 0.25 mcg/kg slowly is administered.

Maintenance Dose:

The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.

Interventions

Dexmedetomidine

Loading Dose:

Dexmedetomidine is usually administered as a loading dose of 0.25 mcg/kg slowly.

Maintenance Dose:

After the loading dose, the maintenance infusion rate is typically 0.2 to 0.7 mcg/kg/hour in syringe pump . The exact rate can be adjusted based on the hemodynamics of the patient (blood pressure and heart rate) and the patient's response.

Intervention Type: DRUG

Dexmedetomidine and ketamine ( Ketodex )

Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):

Ketamine Component:

Loading Dose:

Ketamine is typically given at a dose of 0.5 mg/kg as a bolus injection.

Maintenance Dose:

A maintenance infusion of 0.2 to 0.5 mg/kg/hour is common to maintain anesthesia in syringe pump.

Dexmedetomidine Component:

Loading Dose:

As with the dexmedetomidine group, a loading dose of 0.25 mcg/kg slowly is administered.

Maintenance Dose:

The maintenance infusion rate for dexmedetomidine remains 0.2 to 0.7 µg/kg/hour in syringe pump.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age Range: Patients aged 18-60 years who are scheduled for elective Ear and nose surgeries requiring controlled hypotensive anesthesia.
• ASA Classification: Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
• Surgical Procedures: Individuals undergoing specific ear and nose surgeries where controlled hypotensive anesthesia is typically indicated.
• Stable Cardiovascular Health: Patients with stable cardiovascular function, without significant history of uncontrolled hypertension , hypotension or ischaemic heart diseases.

Exclusion Criteria

• Severe Cardiovascular Conditions: Patients with severe cardiovascular diseases such as congestive heart failure, uncontrolled hypertension , arrhythmias or ischaemic heart diseases .
• Any cardiac patients.
• Respiratory Conditions: Individuals with significant respiratory conditions like chronic obstructive pulmonary disease (COPD) or severe asthma.
• Drug Allergies: Patients with known hypersensitivity or allergic reactions to dexmedetomidine, ketamine or any other components of the study drugs.
• Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks to the fetus or infant.
• Chronic Medication Use: Patients on chronic medications that could interfere with blood pressure regulation or interact with the study drugs (e.g., beta-blockers, MAO inhibitors).
• Patients with chronic liver or renal diseases.
• Psychiatric or Neurological Disorders: Individuals with severe psychiatric or neurological disorders that could impact the study outcomes or the patient's ability to consent.
• Substance Abuse: Patients with a history of substance abuse, particularly involving sedatives or opioids, which could affect anesthesia requirements or recovery.
• Coagulation Disorders: Individuals with coagulation disorders or on anticoagulant therapy, due to the increased risk of bleeding.

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

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Madonna Samir Sobhy

Anesthesia resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Magdy M Amin

Role: primary

Portal@med.sohag.edu.eg

0934602963

Other Identifiers

Soh-Med--25-4-02MS

Identifier Type: -

Identifier Source: org_study_id