Comparison of the Hemodynamic Effects of Ketamine - Dexmedetomidine (Ketodex) Versus Propofol-ketamine Admixture (Ketofol) During Induction of Anesthesia in Elderly: A Randomized Comparative Study

Last updated: July 10, 2025
Sponsor: Kasr El Aini Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ketamine-dexmedetomidine admixture induction of Anesthesia

Clinical Study ID

NCT07002073
MD-451-2024
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To compare the hemodynamic effects of Ketamine-Dexmedetomidine admixture (Ketodex) versus propofol-ketamine admixture (Ketofol) during induction of anesthesia in elderly

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants will be elderly patients (>65 years), ASA I-III, scheduled for electivenon-cardiac surgery under general anesthesia.

Exclusion

Exclusion Criteria:

  • Patients with severe cardiac morbidities (impaired contractility with ejectionfraction < 50%, heart block, arrhythmias, tight valvular lesions, metabolicequivalent [MET] less than 4, patients on angiotensin converting enzyme inhibitorsand angiotensin receptor blockers medications, patients with uncontrolledhypertension, patients undergoing adrenalectomy, patients with body mass index <18or > 35 Kg/m2), patient with allergy of any of the study drugs will be excluded fromthe study and if the patient is considered to be difficult intubation inpreoperative assessment will be excluded as well.

Study Design

Total Participants: 102
Treatment Group(s): 1
Primary Treatment: ketamine-dexmedetomidine admixture induction of Anesthesia
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
February 15, 2026

Study Description

This study details the protocol for anesthetic induction and maintenance, allocating patients into Ketodex (KD) and Ketofol (KP) groups. Prior to anesthesia, a fluid challenge (4 mL/kg over 10 minutes) was administered to assess volume status, with repeated challenges until pulse pressure increased by less than 15% of baseline. For induction, all patients received 1 mg/kg lidocaine. KD patients then received 1 mg/kg ketamine + 0.5 µg/kg dexmedetomidine over 10 minutes, while KP patients received 0.15-0.20 mL/kg of a ketofol admixture. Loss of consciousness, defined by no response to auditory commands and absent eyelash reflex, led to the administration of 0.6 mg/kg rocuronium. After 2 minutes of mask ventilation, an endotracheal tube was inserted. Anesthesia was maintained with isoflurane (0.9-1% end-tidal), and Ringer's lactate solution was infused at 4 mL/kg/hour. Hemodynamic stability was rigorously managed: hypotension (mean blood pressure (MBP) ≤ 80% of baseline and/or MBP < 60 mmHg) occurring up to 15 minutes post-intubation or skin incision was treated with 5 µg norepinephrine boluses, repeatable every 2 minutes. Severe post-induction hypotension (MBP ≤ 60% of baseline) prompted 5 µg norepinephrine boluses every minute, with 1-minute interval blood pressure monitoring. Hypertension (mean arterial pressure > 120% of baseline) was managed with 0.25 mg/kg IV propofol, while bradycardia (heart rate < 45 bpm) was treated with 0.5 mg IV atropine. Blood pressure and heart rate were continuously monitored at specified intervals, with subsequent hemodynamic management left to the discretion of the attending anesthetist after 15 minutes post-intubation or skin incision.

Connect with a study center

  • Cairo University Hospitals

    Cairo, Giza
    Egypt

    Active - Recruiting

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