- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654064
Comparing Fetoscopic Surgery Protocols
December 7, 2022 updated by: Children's Hospital Medical Center, Cincinnati
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Withdrawn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
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Remifentanil-dexmedetomidine
|
Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
|
Active Comparator: 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
Time Frame: Immediately after procedure completion
|
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
Time Frame: Immediately after procedure completion
|
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
Time Frame: 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
|
6 hours after procedure completion
|
Determine patient satisfaction with dexmedetomidine-fentanyl sedation
Time Frame: 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
|
6 hours after procedure completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedation scores
Time Frame: 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
|
Every 15 minutes from start of procedure to one hour post-operative
|
Side-effect measures
Time Frame: Up 24 hours after procedure
|
Incidences of medication side effects will be collected
|
Up 24 hours after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mario Patino, MD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Minimally Invasive Fetoscopic Procedures
-
MedtronicRecruitingSurgical Procedures, Operative | Minimally Invasive Surgical ProceduresUnited States
-
Xact Robotics Ltd.WithdrawnCT-guided Minimally Invasive Procedures e.g. BiopsiesUnited States, Israel
-
Xact Robotics Ltd.CompletedCT-guided Minimally Invasive Procedures e.g., BiopsiesIsrael, United States
-
Microline Surgical, Inc.AKRN Scientific Consulting, S.L.Active, not recruitingLaparoscopy | Minimally Invasive Surgical Procedures | Leakage of Cardiac DeviceSpain, Portugal
-
National Taiwan University HospitalCompletedMinimally Invasive Surgical Procedures
-
Szeged UniversityAlpha - Bio Tec Ltd.; dicomLAB Ltd.CompletedDental Implants | Surgery, Computer-Assisted | Minimally Invasive Surgical Procedures | Surgery, Oral | Dental Implantation, EndosseousHungary
-
University GhentCatharina Ziekenhuis Eindhoven; Vlaamse Vereniging voor Obstetrie en Gynaecologie and other collaboratorsCompletedMyoma | Hysteroscopy | Uterine Septum | Polyp | Minimally Invasive Surgical Procedures | Placental Remnant | Adhesiolysis
-
Mayo ClinicCompletedSurgical Procedures, Minimally Invasive | Blood Coagulation, DisordersUnited States
-
Dr.Gerhard KaufmannCompletedHallux Valgus | Minimally Invasive Surgical ProceduresAustria
-
Rhode Island HospitalRecruitingSpine | Minimally InvasiveUnited States
Clinical Trials on Remifentanil-dexmedetomidine
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedIntubation | SedationChina
-
Yonsei UniversityCompleted
-
Shanghai Ninth People's Hospital Affiliated to...CompletedIntubation; DifficultChina
-
Yonsei UniversityRecruitingPatients With Atrial Fibrillation Undergoing Catheter AblationKorea, Republic of
-
Yonsei UniversityCompletedObstructive Sleep ApneaKorea, Republic of
-
Yonsei UniversityCompletedEarly Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal DissectionKorea, Republic of
-
The Cooper Health SystemCompletedCarotid Artery StenosisUnited States
-
Yeungnam University College of MedicineCompleted
-
Yonsei UniversityCompletedThyroidectomyKorea, Republic of
-
Yeungnam University College of MedicineRecruitingPost Operative Sore ThroatKorea, Republic of