Comparison of the Hemodynamic Effects of Ketamine - Dexmedetomidine (Ketodex) Versus Propofol-ketamine Admixture (Ketofol) During Induction of Anesthesia in Elderly: A Randomized Controlled Study.
- Conditions
- Ketamine-dexmedetomidine Induction of Anesthesia
- Interventions
- Drug: ketamine-dexmedetomidine admixture induction of Anesthesia
- Registration Number
- NCT07002073
- Lead Sponsor
- Kasr El Aini Hospital
- Brief Summary
To compare the hemodynamic effects of Ketamine-Dexmedetomidine admixture (Ketodex) versus propofol-ketamine admixture (Ketofol) during induction of anesthesia in elderly
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- Participants will be elderly patients (>65 years), ASA I-III, scheduled for elective non-cardiac surgery under general anesthesia.
- 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 of any of the study drugs will be excluded from the study and if the patient is considered to be difficult intubation in preoperative assessment will be excluded as well.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketamine-dexmedetomidine admixture induction of Anesthesia ketamine-dexmedetomidine admixture induction of Anesthesia - propofol - ketamine admixture induction of Anesthesia ketamine-dexmedetomidine admixture induction of Anesthesia -
- Primary Outcome Measures
Name Time Method Incidence of post-induction hypotension 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cairo University Hospitals
🇪🇬Cairo, Giza, Egypt