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This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.
Intrathecal adjuncts are commonly added to local anesthetic agents, to improve the duration of nerve blocks and postoperative pain relief without increasing the dosage of local anesthetic.
Studies have shown that dexmedetomidine (DEX) has a greater potential for enhancing analgesic effects due to its higher specificity for alpha2 adrenoceptors. DEX is commonly used for sedation and as an adjunct to reduce the amount of anesthesia and opioids required during general and regional anesthesia in both adults and children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg. |
|
| Group II | Experimental | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg. |
|
| Group III | Experimental | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine 4 μg | Drug | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to request rescue analgesia | Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room. | In the recovery room (Up to 2 hours) |
| Mean arterial blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
Male patients scheduled for knee orthopedic surgery.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A Ismail, MSc | Contact | 00201115746779 | ahmed.ali39348@postgrad.kasralainy.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Dexmedetomidine 8 μg | Drug | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg. |
|
| Dexmedetomidine 12 μg | Drug | Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg. |
|
Mean arterial blood pressure will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room.
| In the recovery room (Up to 2 hours) |
| Respiratory rate | Respiratory rate will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room. | In the recovery room (Up to 2 hours) |
| Oxygen saturation | Oxygen saturation will be recorded every two minutes for the first ten minutes and then every five minutes until the end of surgery and then in the recovery room. | In the recovery room (Up to 2 hours) |