Comparing Fetoscopic Surgery Protocols

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

Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures

Study Overview

• Status: Withdrawn
• Conditions: Minimally Invasive Fetoscopic Procedures
• Intervention / Treatment: Drug: Remifentanil-dexmedetomidine; Drug: Dexmedetomidine-fentanyl

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Remifentanil; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: 2022-0168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No