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Completed

NCT Number: NCT07002073

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, Giza Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients (>65 years)
  • ASA physical status I-III
  • Elective non-cardiac surgery under general anesthesia.

Exclusion criteria

  • Patients with severe cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions, metabolic equivalent [MET] less than 4
  • Patients on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers medications
  • Patients with uncontrolled hypertension
  • patients undergoing adrenalectomy
  • patients with body mass index <18 or > 35 kg/m²
  • patient with allergy to any of the study drugs.
  • patient is considered to be a difficult intubation in the preoperative assessment.

Treatment and study plan

Intravenous Induction of Anesthesia

Drug

To compare incidence of hypotension following ketodex versus ketofol during intavenous induction of general anesthesia in elderly patients

Other names: Effect of drug mixtures on hypotension during induction of Anesthesia in elderly patients

Primary outcomes

  1. Incidence of post-induction hypotension

    Time frame: 12 months

    Incidence of post-induction hypotension (MBP ≤80% of baseline or <60 mmHg) during the period from induction of anesthesia until 16-minutes after intubation providing that skin incision will be after 16-minutes interval.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.