Surgical Conditions During Laparoscopic Bariatric Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/23/2018 |
| Start Date: | May 2016 |
| End Date: | October 2017 |
A Prospective Randomized Clinical Trial Evaluating Surgical Conditions During Laparoscopic Bariatric Surgery With Deep Versus Moderate Neuromuscular Blockade
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.
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.
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.
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.
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
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