Comparing Fetoscopic Surgery Protocols

Study Overview
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Brief Summary
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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

Official Title
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Comparison of Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl Sedation Protocols for Pregnant Patients Undergoing Minimally Invasive Fetoscopic Procedures

Conditions
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Minimally Invasive Fetoscopic Procedures

Intervention / Treatment
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* Drug: Remifentanil-dexmedetomidine
* Drug: Dexmedetomidine-fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant patients undergoing one of the following procedures Laser photocoagulation of abnormal anastomotic vessels in patients with a twin-twin transfusion syndrome Selective radiofrequency ablation or fetoscopic cord coagulation in patients with TRAP sequence or in the presence of intrauterine death of one twin Vesicoamniotic shunts or placement of amnioports in patients with LUTO Placement of amnioports in patients with oligohydramnios or anhydramnios Fetal thoracentesis or placement of thoracoamniotic shunts in patients with congenital pulmonary airway malformation or fetal hydrothorax FETO (fetoscopic endotracheal occlusion) as well as balloon removal in patients with congenital diaphragmatic hernia and laser release of amniotic bands Exclusion Criteria: Pregnant patients undergoing fetoscopic procedures requiring the following Additional procedures (e.g. cerclage) Laparotomy with uterine exteriorization to access the uterine cavity General anesthesia Mid-gestation neural tube defect repair EXIT procedures Preoperative opioid use Diagnosed substance abuse Moderate to severe obstructive sleep apnea History of allergic reactions to medications to be administered during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil-dexmedetomidine<br> | Drug: Remifentanil-dexmedetomidine<br>* Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.<br>|
| Active Comparator: Dexmedetomidine- fentanyl<br> | Drug: Dexmedetomidine-fentanyl<br>* Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Side-effect measures | Incidences of medication side effects will be collected | Up 24 hours after procedure |