Minimally Invasive Fetoscopic Procedures
Conditions
Brief summary
Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures
Interventions
DRUGRemifentanil-dexmedetomidine
Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
DRUGDexmedetomidine-fentanyl
Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participant and surgeon will be blinded to which combination of medications are used during the procedure.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine surgeon satisfaction with remifentanil-dexmedetomidine sedation | Immediately after procedure completion | Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate |
| Determine surgeon satisfaction with dexmedetomidine-fentanyl sedation | Immediately after procedure completion | Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate |
| Determine patient satisfaction with remifentanil-dexmedetomidine sedation | 6 hours after procedure completion | Iowa Satisfaction with Anesthesia Scale (ISAS) 11 question survey rating anesthesia experience. Six response options from disagree very much to agree very much |
| Determine patient satisfaction with dexmedetomidine-fentanyl sedation | 6 hours after procedure completion | Iowa Satisfaction with Anesthesia Scale (ISAS) 11 question survey rating anesthesia experience. Six response options from disagree very much to agree very much |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation scores | Every 15 minutes from start of procedure to one hour post-operative | 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 |
| Side-effect measures | Up 24 hours after procedure | Incidences of medication side effects will be collected |
Outcome results
None listed