Minimally Invasive Fetoscopic ProceduresNCT05654064
Comparing Fetoscopic Surgery Protocols
A study testing Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl in people with Minimally Invasive Fetoscopic Procedures, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Minimally Invasive Fetoscopic Procedures
- What is being tested?
- Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Preoperative opioid use
- Diagnosed substance abuse
- Moderate to severe obstructive sleep apnea
- History of allergic reactions to medications to be administered during the study
About this study
Official title: 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
- Conditions
- Minimally Invasive Fetoscopic Procedures
- Being tested
- Remifentanil-dexmedetomidine, Dexmedetomidine-fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil-dexmedetomidineDrug
Compare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
Dexmedetomidine-fentanylDrug
Compare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil-dexmedetomidine | Active comparator | Not described Receives: Drug: Remifentanil-dexmedetomidine |
| Dexmedetomidine- fentanyl | Active comparator | Not described Receives: Drug: Dexmedetomidine-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine surgeon satisfaction with remifentanil-dexmedetomidine sedation
Surgeons will use a scale of 1-4, 1 - Excellent, 2 - Good, 3 - Moderate, 4 - Inadequate
Measured: 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
Measured: 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
Measured: 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
Measured: 6 hours after procedure completion
Secondary outcomes (2)
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
Measured: Every 15 minutes from start of procedure to one hour post-operative
Side-effect measures
Incidences of medication side effects will be collected
Measured: Up 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Why it stopped: Deferred by IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive Fetoscopic ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Patino, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654064
- Sponsor's protocol ID
- 2022-0168
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl Sedation Protocols for Pregnant Patients Undergoing Minimally Invasive Fetoscopic Procedures
- ClinicalTrials.gov ID
- NCT05654064
- Acronym / sponsor ID
- 2022-0168
- Conditions
- Minimally Invasive Fetoscopic Procedures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Deferred by IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine surgeon and patient satisfaction with remifentanil-dexmedetomidine (REMI) and dexmedetomidine-fentanyl (DEX) sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil-dexmedetomidine | Active comparator | Drug: Remifentanil-dexmedetomidine |
| Dexmedetomidine- fentanyl | Active comparator | Drug: Dexmedetomidine-fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remifentanil-dexmedetomidineCompare adequacy of remifentanil-dexmedetomidine sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures. | Drug | Remifentanil-dexmedetomidine |
| Dexmedetomidine-fentanylCompare adequacy of dexmedetomidine-fentanyl sedation protocols in pregnant patients undergoing minimally invasive fetoscopic procedures. | Drug | Dexmedetomidine- fentanyl |
Primary outcome
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
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
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
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
2 secondary outcomes
Sedation scores
Time frame: Every 15 minutes from start of procedure to one hour post-operative
Side-effect measures
Time frame: Up 24 hours after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Patino, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil-dexmedetomidine and Dexmedetomidine-fentanyl in people with Minimally Invasive Fetoscopic Procedures, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine surgeon satisfaction with remifentanil-dexmedetomidine sedation (time frame: Immediately after procedure completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.