AnesthesiaPhase 4Remi-dexNCT02799589
Remifentanil-dexmedetomidine Anesthesia With a Caudal for Elective Surgery. (Remi-dex)
A Phase 4 study testing Remifentanil, Dexmedetomidine and Ropivacaine in people with Anesthesia, run by Mofya Diallo.
Trial summary
This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in combination with a caudal block for patients ages 1 year to 3 years old receiving elective surgery to investigate alternatives to the currently used volatile anesthetics. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remifentanil, Dexmedetomidine and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Nov 2017
- Phase
- Phase 4
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 - 3 years undergoing urologic surgery (circumcision, hydrocele repair, orchidopexy, mild hypospadias) or inguinal hernia repair
- American Society of Anesthesiologist Physical Status (ASA-PS) I or II
- Eligible for caudal block
- Parental/legal guardian consents for study '
Who cannot join
- Allergy to remifentanil, dexmedetomidine or ropivacaine
- Family history of malignant hyperthermia
- Parental/legal guardian refusal
- ASA-PS ≥ 3
- Symptoms of upper respiratory infection (URI) within the 2 weeks prior to surgery
- Known spinal deformity, presence of sacral dimple, or signs of infection at the site of the caudal block (e.g. diaper rash, skin redness or tenderness).
About this study
Official title: Remifentanil-dexmedetomidine Anesthesia as an Alternative Anesthetic for Elective Pediatric Surgery: a Pilot Study.
This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in combination with a caudal block for patients ages 1 year to 3 years old receiving elective surgery to investigate alternatives to the currently used volatile anesthetics.
Read the detailed description
In light of the concern for potential anesthetic neurotoxicity in infants and toddlers, it is prudent to start investigating alternative methods to decrease the amount of volatile anesthetic being utilized in this patient population. The US Food and Drug Administration has been asked to evaluate the data showing the neurotoxic effects of multiple anesthetic agents in animal models and humans. These studies have shown that N-methyl-D-aspartate (NMDA) receptor blockers such as ketamine,and gamma-Aminobutyric acid receptor (GABA) modulators like benzodiazepines, nitrous, propofol, barbiturates and isoflurane have been shown to cause brain cell apoptosis in animal models.
Regional anesthesia provides both intraoperative and postoperative analgesia may play a major role in effectively reducing the amount of general anesthetic used. Caudal anesthesia has been proven be both safe, effective and is applied widely in the pediatric population.
Dexmedetomidine is a selective alpha2-adrenergic agonist that acts in the brainstem by inhibiting norepinephrine release. Dexmedetomidine is commonly used off-label, including use for duration greater than 24 hours and any use in pediatrics. Dexmedetomidine has relatively few adverse events when compared to other sedative agents, with hypotension and bradycardia being most common.
Remifentanil has a rapid onset, rapid offset, small volume of distribution, rapid clearance, and a short elimination half-life, It may be a useful anesthetic for pediatric outpatient surgery.
While the current standard of care involves a volatile general anesthetic with a caudal block, anesthesiologists have alternative methods that can be utilized to allow an elective surgery to be performed. In summary, this study intends to show the efficacy and safety of a remifentanil-dexmedetomidine infusion and caudal block for patients ages 1 year-3 years old receiving elective circumcision, hydrocele repair, orchidopexy, mild hypospadias or inguinal hernia repair. This alternative anesthetic is already being studied in children under 12 months.
- Conditions
- Anesthesia
- Being tested
- Remifentanil, Dexmedetomidine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min)
DexmedetomidineDrug
Also called Precedex
1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr)
RopivacaineDrug
Also called Naropin
Caudal anesthesia block with Ropivicaine 0.2% 1ml/kg injected into the caudal space
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil-dexmedetomidine and caudal | Experimental | Anesthesia will be induced with inhaled sevoflurane which will be discontinued once IV access is obtained and the airway is secured with an endotracheal tube. Patients will receive remifentanil loading dose of 1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min) and dexmedetomidine load at 1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr) A caudal block with 0.2% ropivacaine will be performed in all patients for intraoperative and postoperative pain control. Receives: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring intervention for light anesthesia
Identified by patient movement, change in mean arterial pressure >80 at surgical incision, need to change anesthetic plan
Measured: 90-120 mins (length of surgery)
Secondary outcomes (4)
Time to recovery after anesthesia
Time from end of surgery to: extubation; time to discharge from post-anesthesia care unit (PACU)
Measured: 10 mins; 1- 4 hours
Number of patients requiring rescue analgesia in PACU
Use of Fentanyl, Morphine, Ketorolac in recovery unit,
Measured: 30 mins to 4 hours after surgery
Number of patients with pain after surgery
Pain is assessed after recovery on Face, Legs, Activity, Cry, Consolability (FLACC) scale 0 to 10. Average score will be noted.
Measured: 1 to 4 hours
Number of patients with respiratory event
Bronchospasm, laryngospasm and pulse oximetry desaturation to less than 90%
Measured: Anesthesia start to discharge from PACU usually 2- 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJul 2016 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mofya Diallo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mofya Diallo, Children's National Research Institute
- Investigators
- Mofya Diallo, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799589
- Sponsor's protocol ID
- Pro00006472
- Acronym
- Remi-dex
- Status last verified
- Apr 2021
- First submitted
- 6 Jun 2016
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil-dexmedetomidine Anesthesia as an Alternative Anesthetic for Elective Pediatric Surgery: a Pilot Study.
- ClinicalTrials.gov ID
- NCT02799589
- Acronym / sponsor ID
- Remi-dex / Pro00006472
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mofya DialloUniversity, hospital or other
- Study start
- Jul 2016 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- 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.
This study intends to show the efficacy of remifentanil-dexmedetomidine infusions in combination with a caudal block for patients ages 1 year to 3 years old receiving elective surgery to investigate alternatives to the currently used volatile anesthetics.
Detailed description
In light of the concern for potential anesthetic neurotoxicity in infants and toddlers, it is prudent to start investigating alternative methods to decrease the amount of volatile anesthetic being utilized in this patient population. The US Food and Drug Administration has been asked to evaluate the data showing the neurotoxic effects of multiple anesthetic agents in animal models and humans. These studies have shown that N-methyl-D-aspartate (NMDA) receptor blockers such as ketamine,and gamma-Aminobutyric acid receptor (GABA) modulators like benzodiazepines, nitrous, propofol, barbiturates and isoflurane have been shown to cause brain cell apoptosis in animal models.
Regional anesthesia provides both intraoperative and postoperative analgesia may play a major role in effectively reducing the amount of general anesthetic used. Caudal anesthesia has been proven be both safe, effective and is applied widely in the pediatric population.
Dexmedetomidine is a selective alpha2-adrenergic agonist that acts in the brainstem by inhibiting norepinephrine release. Dexmedetomidine is commonly used off-label, including use for duration greater than 24 hours and any use in pediatrics. Dexmedetomidine has relatively few adverse events when compared to other sedative agents, with hypotension and bradycardia being most common.
Remifentanil has a rapid onset, rapid offset, small volume of distribution, rapid clearance, and a short elimination half-life, It may be a useful anesthetic for pediatric outpatient surgery.
While the current standard of care involves a volatile general anesthetic with a caudal block, anesthesiologists have alternative methods that can be utilized to allow an elective surgery to be performed. In summary, this study intends to show the efficacy and safety of a remifentanil-dexmedetomidine infusion and caudal block for patients ages 1 year-3 years old receiving elective circumcision, hydrocele repair, orchidopexy, mild hypospadias or inguinal hernia repair. This alternative anesthetic is already being studied in children under 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remifentanil-dexmedetomidine and caudal | Experimental | Drug: Remifentanil, Drug: Dexmedetomidine, Drug: RopivacaineAnesthesia will be induced with inhaled sevoflurane which will be discontinued once IV access is obtained and the airway is secured with an endotracheal tube. Patients will receive remifentanil loading dose of 1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min) and dexmedetomidine load at 1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr) A caudal block with 0.2% ropivacaine will be performed in all patients for intraoperative and postoperative pain control. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1 - 3 years undergoing urologic surgery (circumcision, hydrocele repair, orchidopexy, mild hypospadias) or inguinal hernia repair
- American Society of Anesthesiologist Physical Status (ASA-PS) I or II
- Eligible for caudal block
- Parental/legal guardian consents for study '
Key exclusion criteria (6 listed)
- Allergy to remifentanil, dexmedetomidine or ropivacaine
- Family history of malignant hyperthermia
- Parental/legal guardian refusal
- ASA-PS ≥ 3
- Symptoms of upper respiratory infection (URI) within the 2 weeks prior to surgery
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 |
|---|---|---|
| RemifentanilAlso: Ultiva1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min) | Drug | Remifentanil-dexmedetomidine and caudal |
| DexmedetomidineAlso: Precedex1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr) | Drug | Remifentanil-dexmedetomidine and caudal |
| RopivacaineAlso: NaropinCaudal anesthesia block with Ropivicaine 0.2% 1ml/kg injected into the caudal space | Drug | Remifentanil-dexmedetomidine and caudal |
Primary outcome
Number of patients requiring intervention for light anesthesia
Time frame: 90-120 mins (length of surgery)
Identified by patient movement, change in mean arterial pressure >80 at surgical incision, need to change anesthetic plan
4 secondary outcomes
Time to recovery after anesthesia
Time frame: 10 mins; 1- 4 hours
Number of patients requiring rescue analgesia in PACU
Time frame: 30 mins to 4 hours after surgery
Number of patients with pain after surgery
Time frame: 1 to 4 hours
Number of patients with respiratory event
Time frame: Anesthesia start to discharge from PACU usually 2- 6 hours
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 6 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Mofya Diallo, MD principal investigator
Children's National Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Dexmedetomidine and Ropivacaine in people with Anesthesia, run by Mofya Diallo.
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 4 inclusion and 6 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 6 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients requiring intervention for light anesthesia (time frame: 90-120 mins (length of surgery)). 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 6 Apr 2021.