Comparing Fetoscopic Surgery Protocols

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT05654064
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Minimally Invasive Fetoscopic Procedures	Drug: Remifentanil-dexmedetomidine; Drug: Dexmedetomidine-fentanyl	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: Participant and surgeon will be blinded to which combination of medications are used during the procedure.
• Primary Purpose: Other
• Official Title: Comparison of Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl Sedation Protocols for Pregnant Patients Undergoing Minimally Invasive Fetoscopic Procedures
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remifentanil-dexmedetomidine	Drug: Remifentanil-dexmedetomidine; Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Active Comparator: Dexmedetomidine- fentanyl	Drug: Dexmedetomidine-fentanyl; Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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 Outcome Measures

1. 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

2. Side-effect measures [Up 24 hours after procedure]

   Incidences of medication side effects will be collected

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Mario Patino, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT05654064
• Other Study ID Numbers: 2022-0168
• First Posted: Dec 16, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fentanyl; Dexmedetomidine; Remifentanil

Study Results

No Results Posted as of Dec 16, 2022