Ketamine-dexmedetomidine Induction of Anesthesia
Conditions
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.
Interventions
DRUGIntravenous Induction of Anesthesia
To compare incidence of hypotension following ketodex versus ketofol during intavenous induction of general anesthesia in elderly patients
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed