Appendicitis, Surgery
Conditions
Keywords
laparoscopic
Brief summary
This study is designed as a randomized controlled trial with patients assigned to neuromuscular reversal with either sugammadex or neostigmine/glycopyrrolate reversal. The study will not be blinded to the anesthesiologist to allow for appropriate decision-making on timing and dosage of reversal. This is a single-center study.
Detailed description
Patients presenting to the operating room for laparoscopic appendectomy with a diagnosis of acute appendicitis require rapid sequence induction (RSI) due to significant vomiting and concern for increased gastric content. For this reason, succinylcholine-accompanied by neostigmine-is predominantly used in adults for RSI to prevent potential aspiration. Unfortunately, in pediatric patients, there are many concerns about the use of succinylcholine, including complications such as bradycardia, hyperkalemia, dysrhythmias, and cardiac arrest from undiagnosed skeletal muscle myopathy. For many anesthesiologists, these concerns prompted the decision to use a non-depolarizing muscle relaxant such as rocuronium for induction. However, if the standard RSI dose is used, it often results in residual paralysis at the end of short procedures such as laparoscopic appendectomies. It has recently been demonstrated that prolonged paralysis is prevalent even at low doses of rocuronium in pediatric patients. For these reasons, it is imperative to find a way to provide adequate and safe RSI conditions for intubation, appropriate muscle relaxation for laparoscopic procedures, and the ability to quickly reverse neuromuscular blockade in this pediatric population. Sugammadex has the potential to allow for the utilization of an appropriate RSI dose of rocuronium for intubation, as it provides the ability to reverse neuromuscular blockade earlier than the neostigmine reversal, which is currently the standard of care. Retrospective reviews have shown the use of Sugammadex in pediatric patients to be safe and effective. However, there has not been prospective data about the effect on operating room efficiency of brief pediatric procedures such as laparoscopic appendectomies, one of the most common urgent pediatric surgeries performed. There are numerous other potential benefits of using sugammadex over typical reversal, including the quicker return of bowel function, faster time to tolerance of an oral diet, and decreased exposure to volatile anesthesia. The return of bowel function is particularly important in pediatric patients undergoing laparoscopic procedures. The research team hypothesizes that the utilization of sugammadex in pediatrics results in a quicker return to bowel function. This has previously been demonstrated in adults, but data are lacking in the pediatric population. Researchers also hypothesize that patients receiving sugammadex versus neostigmine reversal will have an improved time to tolerance of an oral diet, which may impact wound healing and nutrition. As anesthesiologists often underdose rocuronium in these short procedures, due to a lack of quick reversal options, high levels of volatile anesthesia are utilized to compensate for inadequate muscle relaxation. With the use of sugammadex allowing for proper muscle relaxation throughout the entire case, researchers hypothesize that patients will have a lower total volatile anesthetic exposure during the procedure. This is exceedingly important in pediatric anesthesia, where the detrimental effects of volatile anesthetics on the developing brain have been demonstrated in numerous animal studies.
Interventions
Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or more.
Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients 2-17 years of age * Diagnosis of acute appendicitis * Patient undergoing laparoscopic appendectomy at Children's Healthcare of Atlanta- Egleston. * Parent or Legal Authorized Representative willing to participate, able to understand and sign an informed consent
Exclusion criteria
* Patient with an allergy to Sugammadex or Neostigmine * History of renal dysfunction * Parent or legal guardian unwilling or unable or unable to understand the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Time From Surgery End to Out of the Operating Room (OR) | Up to 2 hours | The time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Time to First Bowel Movement | Up to 48 hours | Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital |
| Total Time to Tolerance of an Oral Diet | Up to 24 hours | The research team will evaluate via the Epic computer record after discharge from the hospital |
| Total Time of Inhalational Anesthesia Exposure | Up to 5 hours (depending on length of surgical procedure) | evaluated via the Epic computer record after discharge from the hospital |
| Length of Stay in the Post-anesthesia Care Unit (PACU) | Up to 5 hours (on average depending on post anesthesia recovery) | PACU length of stay was evaluated via the Epic computer record after discharge from the hospital |
| Hospital Length of Stay (LoS) | Up to 5 days (depending on length of hospitalization) | Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugammadex The reversal agent, Sugammadex, will be administered at the start of closure.
Sugammadex: Participants will receive 4mg/kg for a TOF 0-1 and 2mg/kg for a train of four (TOF) 2 or greater. | 11 |
| Neostigmine/Glycopyrrolate The reversal agent, Neostigmine, will be administered at the start of closure.
Neostigmine/Glycopyrrolate: Participants will receive 0.07mg/kg of Neostigmine and 0.01mg/kg of Glycopyrrolate, administered by anesthesia once at least two twitches are present. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Total | Sugammadex | Neostigmine/Glycopyrrolate |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 11 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.37 years STANDARD_DEVIATION 3.63 | 12.55 years STANDARD_DEVIATION 3.5 | 10.18 years STANDARD_DEVIATION 3.52 |
| 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 | 9 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 2 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 | 10 Participants | 5 Participants | 5 Participants |
| Region of Enrollment United States | 22 participants | 11 participants | 11 participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Total Time From Surgery End to Out of the Operating Room (OR)
The time from the end of surgery to discharge from the OR will be evaluated via the Epic computer chart after discharge from the hospital.
Time frame: Up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Total Time From Surgery End to Out of the Operating Room (OR) | 9.55 minutes | Standard Deviation 3.03 |
| Neostigmine/Glycopyrrolate | Total Time From Surgery End to Out of the Operating Room (OR) | 10.82 minutes | Standard Deviation 4.87 |
Hospital Length of Stay (LoS)
Hospital LoS will be evaluated via the Epic computer record after discharge from the hospital
Time frame: Up to 5 days (depending on length of hospitalization)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Hospital Length of Stay (LoS) | 34.64 hours | Standard Deviation 39.07 |
| Neostigmine/Glycopyrrolate | Hospital Length of Stay (LoS) | 49.51 hours | Standard Deviation 50.56 |
Length of Stay in the Post-anesthesia Care Unit (PACU)
PACU length of stay was evaluated via the Epic computer record after discharge from the hospital
Time frame: Up to 5 hours (on average depending on post anesthesia recovery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Length of Stay in the Post-anesthesia Care Unit (PACU) | 27.91 minutes | Standard Deviation 9.07 |
| Neostigmine/Glycopyrrolate | Length of Stay in the Post-anesthesia Care Unit (PACU) | 37.73 minutes | Standard Deviation 12.65 |
Total Time of Inhalational Anesthesia Exposure
evaluated via the Epic computer record after discharge from the hospital
Time frame: Up to 5 hours (depending on length of surgical procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Total Time of Inhalational Anesthesia Exposure | 121.30 minutes | Standard Deviation 40.14 |
| Neostigmine/Glycopyrrolate | Total Time of Inhalational Anesthesia Exposure | 142.94 minutes | Standard Deviation 34.32 |
Total Time to First Bowel Movement
Time to first bowel movement will be evaluated via the Epic computer record after discharge from the hospital
Time frame: Up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Total Time to First Bowel Movement | 18.4 hours | Standard Deviation 6.7 |
| Neostigmine/Glycopyrrolate | Total Time to First Bowel Movement | 23.78 hours | Standard Deviation 16.74 |
Total Time to Tolerance of an Oral Diet
The research team will evaluate via the Epic computer record after discharge from the hospital
Time frame: Up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Total Time to Tolerance of an Oral Diet | 4.3 hours | Standard Deviation 1.96 |
| Neostigmine/Glycopyrrolate | Total Time to Tolerance of an Oral Diet | 8.05 hours | Standard Deviation 6.75 |