Anterior Cervical Discectomy and Fusion (ACDF)Phase 4NCT03643796
Narcotic Free TIVA and Incidence of Unacceptable Movements Under Anesthesia During ACDF Surgery
A Phase 4 study testing Remifentanil, Ketamine and Dexmedetomidine in people with Anterior Cervical Discectomy and Fusion (ACDF), run by University of Arkansas at 1 site in United States.
Trial summary
This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Cervical Discectomy and Fusion (ACDF)
- What is being tested?
- Remifentanil, Ketamine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 5 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18- to 80-years old
- ASA 1, 2, 3
- 1 or 2 levels ACDF
Who cannot join
- ASA 4
- Seizure disorders
- Chronic narcotic use
- Opiate abuse
- Major cardiac comorbidity, or significantly elevated blood pressure
- Known hypersensitivity to fentanyl analogs, ketamine, or propofol injectable emulsions.
- Known allergy to eggs, egg products, soybeans, or soy products
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: The Effect of a Narcotic Free Total Intravenous Anesthesia on the Outcome and Patient Safety During Anterior Cervical Discectomy and Fusion (ACDF) Surgery: A Randomized Controlled Trial
This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. The investigators wish to test whether a narcotic free anesthetic will result in an overall safer surgery, better patient recovery, and satisfaction. The investigators think also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover faster after surgery , and consume less pain medicines in the postoperative period.
- Being tested
- Remifentanil, Ketamine, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
KetamineDrug
Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
DexmedetomidineDrug
dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil Group | Active comparator | Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia. Receives: Drug: Remifentanil |
| Ketamine and Dexmedetomidine group | Active comparator | dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.
Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation. Receives: Drug: Ketamine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Unacceptable Movement Under General Anesthesia
Gross visible movement reported by the anesthesiologist or surgical team: bucking, chewing, or reaching to the endotracheal tube and induced by nociception, or head manipulation and positioning by the surgical or anesthesiology team or during a motor evoked potential stimulation.
Measured: duration of surgery
Secondary outcomes (4)
Hemodynamic Stability
Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia
Measured: up to 24 hours
Time to Extubation
From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.
Measured: up to 24 hours
Quality of Recovery
( Modified Quality of Recovery score, QoR-15) is a psychometric assessment of recovery from general anesthesia.Answers of 15 questions are given scores from 1 to 10 on a Likert scale. The score ranges from 0 to 150. The questionnaire is designed to assess the emotional state, physical comfort, psychological support, physical independence, and pain. A higher score indicates a better outcome
Measured: 24 hours post-op
Narcotic Consumption
all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start15 Jul 2018
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cervical Discectomy and Fusion (ACDF)Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Abdeldayem, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643796
- Sponsor's protocol ID
- 207374
- Status last verified
- Apr 2023
- First submitted
- 5 Jul 2018
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Narcotic Free Total Intravenous Anesthesia on the Outcome and Patient Safety During Anterior Cervical Discectomy and Fusion (ACDF) Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03643796
- Acronym / sponsor ID
- 207374
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will help the investigators learn more about the best way to give anesthesia for these kinds of surgery. The investigators will be using 2 different groups of medications that is commonly used in ACDF surgery, one group has a Narcotic, and the other group does not. The investigators wish to test whether a narcotic free anesthetic will result in an overall safer surgery, better patient recovery, and satisfaction. The investigators think also that eliminating the Narcotic from the Anesthetic regimen will allow patients to recover faster after surgery , and consume less pain medicines in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil Group | Active comparator | Drug: RemifentanilRemifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia. |
| Ketamine and Dexmedetomidine group | Active comparator | Drug: Ketamine, Drug: Dexmedetomidinedexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18- to 80-years old
- ASA 1, 2, 3
- 1 or 2 levels ACDF
Key exclusion criteria (7 listed)
- ASA 4
- Seizure disorders
- Chronic narcotic use
- Opiate abuse
- Major cardiac comorbidity, or significantly elevated blood pressure
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 |
|---|---|---|
| RemifentanilRemifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia. | Drug | Remifentanil Group |
| KetamineKetamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation. | Drug | Ketamine and Dexmedetomidine group |
| Dexmedetomidinedexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound. | Drug | Ketamine and Dexmedetomidine group |
Primary outcome
Incidence of Unacceptable Movement Under General Anesthesia
Time frame: duration of surgery
Gross visible movement reported by the anesthesiologist or surgical team: bucking, chewing, or reaching to the endotracheal tube and induced by nociception, or head manipulation and positioning by the surgical or anesthesiology team or during a motor evoked potential stimulation.
4 secondary outcomes
Hemodynamic Stability
Time frame: up to 24 hours
Time to Extubation
Time frame: up to 24 hours
Quality of Recovery
Time frame: 24 hours post-op
Narcotic Consumption
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Abdeldayem, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Ketamine and Dexmedetomidine in people with Anterior Cervical Discectomy and Fusion (ACDF), run by University of Arkansas at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Unacceptable Movement Under General Anesthesia (time frame: duration 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 18 Sep 2023.