Morbid Obesity
Conditions
Keywords
morbid obesity, laparoscopic surgery, neuromuscular blockade
Brief summary
Obesity affects more than 78 million adults in the United States and it is estimated that 35% of the US population is obese. Currently, more than 179,000 bariatric procedures are performed in the US each year with the majority of these surgeries using laparoscopic techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but there is no evidence that a deep NMB improves surgical conditions and that the surgeons can discriminate between a moderate and deep NMB. There is also evidence that maintaining low insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize lower insufflation pressure and decreases postoperative pain requirements after laparoscopic bariatric surgery.
Detailed description
Subjects will be randomized to one of four groups: 1. moderate neuromuscular block (NMB) + 10 mm insufflation pressure (IP); 2. moderate NMB + 15 mm IP; 3. deep NMB + 10 mm IP; or 4. deep NMB + 15 mm IP. A moderate NMB block will be defined as 2-3 twitches in the train of four (TOF) and a deep NMB will be defined as 0-1 posttetanic count. The surgeons will be asked to rate their satisfaction with the surgical conditions using a five-point ordinal scale ranging from 1 (extremely poor) to 5 (optimal conditions). The first rating will occur at the beginning of the procedure when the NMB level is stable at either a deep or moderate block and the intra-abdominal pressure is either 10 or 15 mm Hg (per randomization). The surgeon will be blinded to the insufflation pressure at this point. If the surgical conditions are rated as extremely poor or poor, the level of the neuromuscular block can be increased and/or the insufflation pressure can be increased to 15 mm Hg.
Interventions
DRUGRocuronium
Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
DEVICEInsufflation pressure
The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
Sponsors
Merck Sharp & Dohme LLC
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * ASA I-III * BMI ≥ 35
Exclusion criteria
* Inability to obtain written informed consent * Pregnancy or breastfeeding * Allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol * Known or suspected neuromuscular disorders * Significant renal disease with a serum creatinine ≥ 2 mg/dl f. Significant liver disease g. A family history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Satisfaction Scale | day of surgery | The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure | day of surgery | The patients will be randomized to an initial insufflation pressure of 10 or 15 mm hg. If the surgeons are not satisfied with the initial operating conditions, the insufflating pressure will be increase to 15 mm Hg (if not already at that level). This will be reported as the percentage of patients who were able to have their entire surgery performed at an insufflation pressure of 10 mm Hg. |
| Postoperative Opioid Requirement | day of surgery until hospital discharge (approximately 2-3 days) | The participants will be given iv fentanyl or hydromorphone after surgery. They will also be given po oxycodone. The investigators will collect data on the amount of opioid that is required after surgery. This will be reported as morphine equivalents using the morphine equivalent calculator at: |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate NMB + 10 mm IP participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment | 36 |
| Moderate NMB + 15 mm IP participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment | 37 |
| Deep NMB + 10 mm IP participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment | 36 |
| Deep NMB + 15 mm IP participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.
Rocuronium: Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
Insufflation pressure: The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment | 35 |
| Total | 144 |
Baseline characteristics
| Characteristic | Moderate NMB + 10 mm IP | Total | Deep NMB + 15 mm IP | Deep NMB + 10 mm IP | Moderate NMB + 15 mm IP |
|---|---|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 8 | 45 years STANDARD_DEVIATION 11 | 44 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 12 | 43 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 14 Participants | 2 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 130 Participants | 33 Participants | 33 Participants | 31 Participants |
| Region of Enrollment United States | 36 participants | 144 participants | 35 participants | 36 participants | 37 participants |
| Sex: Female, Male Female | 30 Participants | 103 Participants | 31 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Male | 6 Participants | 41 Participants | 4 Participants | 28 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 37 | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 0 / 36 | 0 / 37 | 0 / 36 | 0 / 35 |
| serious Total, serious adverse events | 0 / 36 | 0 / 37 | 0 / 36 | 0 / 35 |
Outcome results
Primary
Surgeon Satisfaction Scale
The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions
Time frame: day of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate NMB + 10 mm IP | Surgeon Satisfaction Scale | 2.7 Scores on a scale | Standard Deviation 1 |
| Moderate NMB + 15 mm IP | Surgeon Satisfaction Scale | 4.1 Scores on a scale | Standard Deviation 0.9 |
| Deep NMB + 10 mm IP | Surgeon Satisfaction Scale | 3.1 Scores on a scale | Standard Deviation 1 |
| Deep NMB + 15 mm IP | Surgeon Satisfaction Scale | 4.6 Scores on a scale | Standard Deviation 0.6 |
Secondary
Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure
The patients will be randomized to an initial insufflation pressure of 10 or 15 mm hg. If the surgeons are not satisfied with the initial operating conditions, the insufflating pressure will be increase to 15 mm Hg (if not already at that level). This will be reported as the percentage of patients who were able to have their entire surgery performed at an insufflation pressure of 10 mm Hg.
Time frame: day of surgery
Population: The percentage of patients who were able to have their surgery completed at an IP of 10 mm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate NMB + 10 mm IP | Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure | 10 Participants |
| Moderate NMB + 15 mm IP | Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure | 0 Participants |
| Deep NMB + 10 mm IP | Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure | 14 Participants |
| Deep NMB + 15 mm IP | Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure | 0 Participants |
Secondary
Postoperative Opioid Requirement
The participants will be given iv fentanyl or hydromorphone after surgery. They will also be given po oxycodone. The investigators will collect data on the amount of opioid that is required after surgery. This will be reported as morphine equivalents using the morphine equivalent calculator at:
Time frame: day of surgery until hospital discharge (approximately 2-3 days)
Population: Only 24 of the patients had an IP of 10 mm throughout the surgery. The remainder of the patients either had IP of 15 mm throughout the surgery or were increased to 15 mm at the start of the surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Moderate NMB + 10 mm IP | Postoperative Opioid Requirement | 48.8 morphine equivalents | Standard Deviation 26.6 |
| Moderate NMB + 15 mm IP | Postoperative Opioid Requirement | 56.7 morphine equivalents | Standard Deviation 38.6 |