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The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine ("Ketofol") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.
Primary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketofol Group (Ketamine + Propofol) | Experimental | Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV |
|
| Propofol group ( propofol monotherapy) | Experimental | Patients will take Propofol lowest bolus dose of 0.5 mg/kg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg/kg after hemodynamically assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketofol | Drug | Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial blood pressure | hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 3min , 5min 10min, 20min , 30min , 60min then hourly for 24h. | baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to successful intubation | Time to successful intubation (from induction to tube placement confirmation | within 1 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al Aini Hospital | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032544 | Background | Foo TY, Mohd Noor N, Yazid MB, Fauzi MH, Abdull Wahab SF, Ahmad MZ. Ketamine-propofol (Ketofol) for procedural sedation and analgesia in children: a systematic review and meta-analysis. BMC Emerg Med. 2020 Oct 8;20(1):81. doi: 10.1186/s12873-020-00373-4. | |
| Background | How to cite this article: Padhi S, Singh GP, Chaturvedi A, Rath GP. Effect of ketofol versus propofol on cerebral oxygenation in patients undergoing transsphenoidal pituitary surgery under total intravenous anesthesia - A randomized control trial. J Neurosci Rural Pract. 2025;16:S52-9. doi: 10.25259/JNRP_138_2025 | ||
| 22401952 |
| Label | URL |
|---|---|
| Related Info | View source |
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| propofol (drug) | Drug | Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient |
|
| Background |
| Andolfatto G, Abu-Laban RB, Zed PJ, Staniforth SM, Stackhouse S, Moadebi S, Willman E. Ketamine-propofol combination (ketofol) versus propofol alone for emergency department procedural sedation and analgesia: a randomized double-blind trial. Ann Emerg Med. 2012 Jun;59(6):504-12.e1-2. doi: 10.1016/j.annemergmed.2012.01.017. Epub 2012 Mar 7. |
| 33262033 | Background | El Mourad MB, Shaaban AE, El Sharkawy SI, Afandy ME. Effects of Propofol, Dexmedetomidine, or Ketofol on Respiratory and Hemodynamic Profiles in Cardiac Patients Undergoing Transesophageal Echocardiography: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2021 Sep;35(9):2743-2750. doi: 10.1053/j.jvca.2020.11.013. Epub 2020 Nov 10. |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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