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Deferred by IRB.
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Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil-dexmedetomidine | Active Comparator |
| |
| Dexmedetomidine- fentanyl | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil-dexmedetomidine | Drug | Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine surgeon satisfaction with remifentanil-dexmedetomidine sedation | Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate | Immediately after procedure completion |
| Determine surgeon satisfaction with dexmedetomidine-fentanyl sedation | Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate | Immediately after procedure completion |
| Determine patient satisfaction with remifentanil-dexmedetomidine sedation | Iowa Satisfaction with Anesthesia Scale (ISAS) 11 question survey rating anesthesia experience. Six response options from disagree very much to agree very much | 6 hours after procedure completion |
| Determine patient satisfaction with dexmedetomidine-fentanyl sedation | Iowa Satisfaction with Anesthesia Scale (ISAS) 11 question survey rating anesthesia experience. Six response options from disagree very much to agree very much | 6 hours after procedure completion |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation scores | Assessment of sedation level using a 1 - 5 scale; 1 - No response after name is called loudly with mild shaking, 2 - Responds only after name called loudly and after mild shaking of the body, 3 - Responds only after name called loudly or repeatedly, 4 - Lethargic response to name spoken in normal tone, 5 - Awake and responds to name spoken in normal tone | Every 15 minutes from start of procedure to one hour post-operative |
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Inclusion Criteria:
Pregnant patients undergoing one of the following procedures
Exclusion Criteria:
Pregnant patients undergoing fetoscopic procedures requiring the following
Pregnant females undergoing fetoscopic procedures
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| Name | Affiliation | Role |
|---|---|---|
| Mario Patino, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
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Participant and surgeon will be blinded to which combination of medications are used during the procedure.
| Dexmedetomidine-fentanyl | Drug | Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures. |
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| Side-effect measures | Incidences of medication side effects will be collected | Up 24 hours after procedure |