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

Not Applicable

Recruiting

• Conditions: Ear and Nose Surgeries With Hypotensive Anaesthesia e.g FESS , MLS , TURBINECTOMY
• Interventions: Drug: Dexmedetomidine; Drug: Dexmedetomidine and ketamine ( Ketodex )

• Registration Number: NCT06981494
• Lead Sponsor: Sohag University

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

Study Timeline

• Study First Submitted: 2024-12-26
• Study Start: 2025-02-05
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-08-10
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Group (D)	Dexmedetomidine	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.
Ketodex Group (Combination of Ketamine and Dexmedetomidine) (K):	Dexmedetomidine and ketamine ( Ketodex )	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.

Primary Outcome Measures

Name	Time	Method
Assessment of hemodynmaic stability	6 months	Assess Hemodynamic Stability: Compare the hemodynamic stability provided by dexmedetomidine and ketodex, focusing on parameters such as blood pressure and heart rate will be monitored every 5 minutes and we will record the average every 20 minutes intraoperative . This monitoring will help assess the stability of each patient and the safety profile of the anesthetic agents used in the study.

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Sohag, Egypt