Anterior Cervical Discectomy and Fusion (ACDF)
Conditions
Brief 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. 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.
Interventions
DRUGRemifentanil
Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
DRUGKetamine
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.
DRUGDexmedetomidine
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.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women 18- to 80-years old * ASA 1, 2, 3 * 1 or 2 levels ACDF
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Unacceptable Movement Under General Anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Extubation | up to 24 hours | From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired. |
| Quality of Recovery | 24 hours post-op | ( 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 |
| Hemodynamic Stability | up to 24 hours | Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia |
| Narcotic Consumption | 24 hours | all narcotics and pain medication consumed by subject in the recovery room until discharged will be recorded and compared among 2 study groups. |
Countries
United States
Participant flow
Recruitment details
Recruitment was all done in the Preoperative area at the morning of the surgery
Pre-assignment details
No wash outs or run-in has occurred
Participants by arm
| Arm | Count |
|---|---|
| Remifentanil Group Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia. | 15 |
| Ketamine and Dexmedetomidine Group 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. | 17 |
| Total | 32 |
Baseline characteristics
| Characteristic | Total | Remifentanil Group | Ketamine and Dexmedetomidine Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 13 Participants | 14 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 20 | 46 years STANDARD_DEVIATION 20 | 52 years STANDARD_DEVIATION 19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 13 Participants | 14 Participants |
| Region of Enrollment United States | 32 participants | 15 participants | 17 participants |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 0 / 17 | 0 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 15 |
Outcome results
Primary
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.
Time frame: duration of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Remifentanil Group | Incidence of Unacceptable Movement Under General Anesthesia | 1 Participants |
| Ketamine and Dexmedetomidine Group | Incidence of Unacceptable Movement Under General Anesthesia | 1 Participants |
Secondary
Hemodynamic Stability
Any increase in the heart rate by more than 20% of patient baseline before induction of anesthesia
Time frame: up to 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Remifentanil Group | Hemodynamic Stability | 4 Participants |
| Ketamine and Dexmedetomidine Group | Hemodynamic Stability | 5 Participants |
Secondary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil Group | Narcotic Consumption | 12.7 Morphine Equivalents | Standard Deviation 2.4 |
| Ketamine and Dexmedetomidine Group | Narcotic Consumption | 11.5 Morphine Equivalents | Standard Deviation 2.7 |
Secondary
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
Time frame: 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil Group | Quality of Recovery | 122 units on a scale | Standard Deviation 7 |
| Ketamine and Dexmedetomidine Group | Quality of Recovery | 127 units on a scale | Standard Deviation 8 |
Secondary
Time to Extubation
From start of of emergence from anesthesia until time of extubation. Shorter amount of time between the two, is desired.
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil Group | Time to Extubation | 12 minutes | Standard Deviation 7 |
| Ketamine and Dexmedetomidine Group | Time to Extubation | 18 minutes | Standard Deviation 7 |