Postoperative Nausea and Vomiting, Respiratory Conditions Due to Other External Agents
Conditions
Keywords
sugammadex, post anesthesia care unit recovery
Brief summary
The investigators will track bariatric patients who received sugammadex versus neostigmine in the post anesthesia care unit until discharge and assess their length of stay and possible nausea / vomiting / hypoxia episodes.
Detailed description
During their preadmission testing, patients planning to undergo sleeve gastrectomy bariatric surgeries will be consented (by having them sign consent forms) and recruited for the study. A trained individual will track these patients after the surgery in the post anesthesia care unit until discharge and assess their length of stay and possible nausea / vomiting. The exact time the investigators are looking to assess is patient arrival to the post anesthesia care unit until patient ready for discharge when the anesthesiologist writes the anesthesia evaluation. The time the reversal agent is administered during the start of skin closure until patient medically ready to leave the post anesthesia care unit will also be taken into account. Blinded to the treatment group, the trained individual will ask each patient every 15 minutes after arrival to the post anesthesia care unit if they are experiencing nausea or vomiting. As an exploratory measure, the trained individual will assess the patient at these same times (every 15 minutes) and determine their oxygen saturation. The investigators will take all the data from the observations and use statistical means to measure what is significant. A discussion and conclusion will follow. Finally, the principal investigator will submit the study outcomes to an anesthesia journal.
Interventions
DRUGSugammadex
Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
DRUGNeostigmine
Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
Sponsors
Merck Sharp & Dohme LLC
Virtua Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients having sleeve gastrectomy * Surgeries performed by a particular surgeon - Dr. Sam Wasser * Body Mass Index greater than 35 * American Society of Anesthesiologists Score II and III patients
Exclusion criteria
* Patients having a different type of bariatric surgery including but not limited to duodenal switch, gastric bypass, hand-assisted laparoscopic sleeve gastrectomy * Sleeve gastrectomy's performed by other surgeons than Dr. Sam Wasser. * Pregnancy * Allergic to sugammadex, Zofran or scopolamine * Chronic Obstructive Pulmonary Disease or Asthma that is uncontrolled * American Society of Anesthesiologists Score I, IV, V patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Anesthesia Care Unit Length of Stay | Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes). | Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea and Vomiting | Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes). | Assess the incidence of Postoperative Nausea and Vomiting in the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine at arrival to the post anesthesia care unit and every 15 minutes while in the post anesthesia care unit, with the prediction that there will be a lower incidence of Postoperative Nausea and Vomiting in the Sugammadex group. |
| Incidence of Respiratory Complications | Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes). | Assess the incidence of respiratory complications postoperatively specifically looking at oxygen saturation at patient arrival to the post anesthesia care unit and every 15 minutes after arrival to the post anesthesia care unit and any intervention necessary. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group/Neostigmine The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures. | 34 |
| Study Group/Sugammadex 33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures. | 33 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Study Group/Sugammadex | Total | Control Group/Neostigmine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 61 Participants | 31 Participants |
| Age, Continuous | 42 years | 42 years | 43 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 24 Participants | 12 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 41 Participants | 20 Participants |
| Region of Enrollment United States | 33 participants | 67 participants | 34 participants |
| Sex: Female, Male Female | 25 Participants | 54 Participants | 29 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 |
| other Total, other adverse events | 1 / 34 | 0 / 33 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 |
Outcome results
Primary
Post Anesthesia Care Unit Length of Stay
Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries.
Time frame: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group/Neostigmine | Post Anesthesia Care Unit Length of Stay | 121 minutes |
| Study Group/Sugammadex | Post Anesthesia Care Unit Length of Stay | 119 minutes |
Secondary
Incidence of Postoperative Nausea and Vomiting
Assess the incidence of Postoperative Nausea and Vomiting in the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine at arrival to the post anesthesia care unit and every 15 minutes while in the post anesthesia care unit, with the prediction that there will be a lower incidence of Postoperative Nausea and Vomiting in the Sugammadex group.
Time frame: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group/Neostigmine | Incidence of Postoperative Nausea and Vomiting | Positive for PONV | 14 Participants |
| Control Group/Neostigmine | Incidence of Postoperative Nausea and Vomiting | Negative PONV | 20 Participants |
| Study Group/Sugammadex | Incidence of Postoperative Nausea and Vomiting | Positive for PONV | 14 Participants |
| Study Group/Sugammadex | Incidence of Postoperative Nausea and Vomiting | Negative PONV | 19 Participants |
Secondary
Incidence of Respiratory Complications
Assess the incidence of respiratory complications postoperatively specifically looking at oxygen saturation at patient arrival to the post anesthesia care unit and every 15 minutes after arrival to the post anesthesia care unit and any intervention necessary.
Time frame: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group/Neostigmine | Incidence of Respiratory Complications | Positive for Hypoxia | 2 Participants |
| Control Group/Neostigmine | Incidence of Respiratory Complications | Negative for Hypoxia | 32 Participants |
| Study Group/Sugammadex | Incidence of Respiratory Complications | Negative for Hypoxia | 33 Participants |
| Study Group/Sugammadex | Incidence of Respiratory Complications | Positive for Hypoxia | 0 Participants |