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Ketamine-dexmedetomidine Induction of AnesthesiaNCT07002073

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

A study testing Intravenous Induction of Anesthesia in people with Ketamine-dexmedetomidine Induction of Anesthesia, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Intravenous Induction of Anesthesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 15 Feb 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University Hospitals

    Cairo, Giza Governorate

Other trials in Egypt

About this study

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

Read the detailed 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.

Being tested
Intravenous Induction of Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous Induction of AnesthesiaDrug

    Also called Effect of drug mixtures on hypotension during induction of Anesthesia in elderly patients

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

Study groups in NCT07002073
Study groupRoleWhat they receive
ketamine-dexmedetomidine admixture induction of AnesthesiaActive comparatorIntravenous Induction of Anesthesia Using a Mixture of Ketamine and dexmedetomidine in a ratio of 1 mg ketamine to 0.5 ug dexmedetomidine given in a dose of 1mg/kg ketamine and 0.5 ug/kg dexmedetomidine to elderly patients
Receives: Drug: Intravenous Induction of Anesthesia
propofol - ketamine admixture induction of AnesthesiaActive comparatorIntravenous Induction of Anesthesia Using a Mixture of Ketamine and Propofol in a ratio of 1:1 in elderly patients given in a dose of 1 mg/kg ketamine and 1 mg/kg propofol
Receives: Drug: Intravenous Induction of Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of post-induction hypotension

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start1 Apr 2025
  3. Primary completion30 Nov 2025
  4. Study completion15 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07002073
Sponsor's protocol ID
MD-451-2024
Status last verified
Apr 2026
First submitted
23 May 2025
Last updated
21 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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