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.
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
- Conditions the study is for
- Ketamine-dexmedetomidine Induction of Anesthesia
- 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.
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 group | Role | What they receive |
|---|---|---|
| ketamine-dexmedetomidine admixture induction of Anesthesia | Active comparator | Intravenous 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 Anesthesia | Active comparator | Intravenous 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.
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.
- First posted3 Jun 2025
- Study start1 Apr 2025
- Primary completion30 Nov 2025
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketamine-dexmedetomidine Induction of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Mohamed Ahmed Abdelhafez, Kasr El Aini Hospital
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