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This randomized double-blind parallel clinical study was conducted on 60 patients undergoing elective cardiac surgery under general anesthesia, at least 60 yr old, ASA I and II, 70-100 kg body weight and height 160-180 cm. Patients were randomized to: group A=30 patients receiving dexmedetomidine infusion (0.4- 0.7 µg /kg/h) or group B= 30 patients receiving morphine in a dose of 10-50μg/kg/hr as an analgesic with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg repeated as needed. Titration of the study medications infusions was conducted to maintain light sedation (RASS) (-2 to +1). Primary outcome was the prevalence of delirium measured daily via Confusion Assessment Method for intensive care. If Delirium and agitation occurred: haloperidol 2.5-5 mg IV was given in repeated boluses. Secondary outcomes included ventilation time, additional sedation/analgesia, hemodynamics and adverse effects.
Upon arrival at the ICU, a standardized protocol for postoperative care was implemented for all patients. Infusion rates for all sedative protocols were titrated in order to achieve and maintain light sedation (RASS -2 to +1) before extubation and (RASS 0) after extubation. All patients were extubated when deemed clinically appropriate according to local protocols. Because of their specific pharmacologic properties (i.e., respiratory depression), patients were weaned off propofol or midazolam infusions before extubation, whereas patients receiving dexmedetomidine were extubated while still on the medication and were kept on the maintenance infusion as deemed clinically necessary for a maximum of 24 hours.
Initial assessment and stabilization of both patient groups include; Clinical examination, hemodynamics (invasive blood pressure, heart rate, drains), activated clotting time, electrocardiography, chest x-ray and arterial blood gases including sodium and potassium. All patients were allowed to take 200 μg fentanyl and 5mg midazolam immediately on admission. Daily electrocardiography, chest x-ray, arterial blood gases including sodium and potassium, kidney function, coagulation profile if valve surgery or bleeding occurred, liver function if delirium occurred and CRP quantitative titre.
Delirium was monitored and reassessed up to a maximum of 7 days after surgery and the assessment takes place in two steps; Firstly, the level of consciousness must be assessed using the Richmond Agitation-Sedation Scale. If the patient appears to have a RASS score≥3, then evaluation of delirium using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) can be performed. The CAM-ICU includes the assessment of 4 different features; acute change or fluctuating course of mental status, inattention, altered level of consciousness and disorganized thinking. CAM-ICU is considered positive when features 1 and 2 and either 3 or 4 are present (11). The CAM-ICU was performed once daily before midday, independent of additional analgesia or sedation. Abnormal or delirious behavior was recorded every shift by the bedside nurse (nurse:patient ratio 1:1) and reviewed by the research team. The number of delirium days was determined by following delirious patients until 7 days after surgery. Patients were considered delirium-free when they were free of delirium for more than 24 h and alive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Group (N=30) | Active Comparator |
| |
| Morphine with Midazolam (N=30) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride | Drug | 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Delirium (Number of Patients (in Digits)) | Delirium was reported on day 7 post-surgery | |
| The C-reactive Protein (CRP) Quantitative Titer Daily as Part of the Routine Clinical Care as a Prognostic Factor for Delirium (mg/L) | The maximum serum CRP level during the ICU stay was designated as max-CRP on day 7 post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29628826 | Result | Azeem TMA, Yosif NE, Alansary AM, Esmat IM, Mohamed AK. Dexmedetomidine vs morphine and midazolam in the prevention and treatment of delirium after adult cardiac surgery; a randomized, double-blinded clinical trial. Saudi J Anaesth. 2018 Apr-Jun;12(2):190-197. doi: 10.4103/sja.SJA_303_17. |
| Label | URL |
|---|---|
| https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5875204/ | View source |
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Patients were excluded if: (1) patient's refusal, (2) allergy to any drugs of the study, (3) history of drug or alcohol abuse, (4) history of uncontrolled diabetes or hypertension, (5) history of chronic pain or daily intake of analgesics within 24 h before surgery, and (6) impaired kidney or liver functions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine Group (N=30) | Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h |
| FG001 | Morphine With Midazolam (N=30) | Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine Group (N=30) | Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Delirium (Number of Patients (in Digits)) | Posted | Number | participants | Delirium was reported on day 7 post-surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine Group (N=30) | Dexmedetomidine Hydrochloride: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delirium | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delirium | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ibrahim Mamdouh Esmat | Ain-Shams University Hospitals | 01001241928 | ibrahim_mamdouh@med.asu.edu.eg |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D009020 | Morphine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Morphine and Midazolam | Drug | 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed. |
|
| Morphine With Midazolam (N=30) |
Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | The C-reactive Protein (CRP) Quantitative Titer Daily as Part of the Routine Clinical Care as a Prognostic Factor for Delirium (mg/L) | Posted | Mean | Standard Deviation | mg/L | The maximum serum CRP level during the ICU stay was designated as max-CRP on day 7 post-surgery |
|
|
|
| 1 |
| 30 |
| 1 |
| 30 |
| EG001 | Morphine With Midazolam (N=30) | Morphine and Midazolam: 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed. | 2 | 30 | 2 | 30 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |