Comparing Fetoscopic Surgery Protocols

Not Applicable

Withdrawn

• Conditions: Minimally Invasive Fetoscopic Procedures
• Interventions: Drug: Remifentanil-dexmedetomidine; Drug: Dexmedetomidine-fentanyl

• Registration Number: NCT05654064
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04
• Status Verified: 2022-12
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-16
• Last Update Posted: 2022-12-16
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil-dexmedetomidine	Remifentanil-dexmedetomidine	-
Dexmedetomidine- fentanyl	Dexmedetomidine-fentanyl	-

Primary Outcome Measures

Name	Time	Method
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 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 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
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

Secondary Outcome Measures

Name	Time	Method
Side-effect measures	Up 24 hours after procedure	Incidences of medication side effects will be collected
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