Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LD-DEX | Active Comparator | This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml). |
|
| Control group | No Intervention | This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 10μg dexmedetomidine will be added to the injectate to be injected intrathecally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Density of motor and sensory blockade | Intraoperative | |
| Haemodynamic stability and total doses of IV fluids and vasopressors | Intraoperative | |
| Time to first postoperative rescue analgesic request | 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| The intraoperative patient and surgeon satisfaction (successful delivery) | Intraoperative | |
| The peak sensory level of block | Intraoperative | |
| Time from intrathecal injection to peak sensory block level |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mamdoh Lotfy, Prof. Dr. | Faculty of Medicine - Menoufia University | Study Chair |
| Safaa M Helal, Prof. Dr. | Faculty of Medicine - Menoufia University | Study Chair |
| Wesameldin A Soltan, Dr. | Faculty of Medicine - Menoufia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University Hospitals | Shibīn al Kawm | Menoufia | Egypt |
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intraoperative |
| The time to two sensory block segment regression | Intraoperative and 24 hour |
| Degree and duration of motor block | Intraoperative and 24 hour |
| Intraoperative analgesic supplementation during operation | Intraoperative |
| Postoperative pain scores for 24 hours | 24 hour |
| Frequency and total dose of postoperative analgesics | 24 hour |
| Intraoperative and postoperative sedation scores | Intraoperative and 24 hour |
| Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation. | Intraoperative and 24 hour |
| Hospital in stay | 24 hour |
| Time to S1 level sensory regression | Intraoperative and 24 hour |