Moderate vs. Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy

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Koo BW, et al. "Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy". World J Surg. 2016. 40(12):2989-2903.
PubMed

Clinical Question

In patients who undergo an elective laparoscopic cholecystectomy does the use of deep neuromuscular blockade allow for the use of low pressure pneumoperitoneum?

Bottom Line

The use of deep neuromuscular blockade along with reversal from sugammadex allows for the use of lower intra-abdominal inflation pressures during elective laparoscopic cholecystectomies. It was associated with better patient outcomes in terms of pain and recovery, and increased surgeon satisfaction with the visual field.

Major Points

In order to maintain an adequate field of vision in laparoscopic procedures surgeons typically increase the intra-abdominal pressure by add more carbon dioxide gas into the abdomen. While this optimizes the surgical field, it has negative impacts on the patients hemodynamic state. Further, the benefits of low pressure pneumoperitonemum compared to high pressure have been demonstrated in several studies [1][2][3]. Deep neuromuscular blockade was not used in the pat due to a lack of an effective reversal agent. Now with the introduction of sugammadex (a new reveral agent), immediate complete reversal is possible [4]. Presently, there is limited evidence about the effects of deep neuromuscular blocks on intra-abdominal pressure (IAP) in laparoscopic procedures.

In this study the team evaluated the effect of intraoperative deep neuromuscular blockade on surgical conditions in laparoscopic cholecystectomy during low pressure pneumoperitoneum. Based on available literature the authors estimated that deep neuromuscular blockade would result in a 30 % or greater reduction in incidence of surgeons increasing the IAP compared to standard, moderate neuromuscular blockade. This research found that the rate of needing to increase IAP was significantly lower in the deep group compared to the moderate group (34.4% vs 12.5%).

The authors concluded that using deep neuromuscular blockade with full reversal with sugammadex allows for the use of lower IAPs in elective laparoscopic cholecystectomies. Lower IAP is associated with decreased pain, more stable intraoperative hemodynamics, better pulmonary function. Deep neuromuscular blockade was further associated with lower postoperative residual muscular paresis.

Guidelines

No guidelines have been published that reflect the results of this trial.

Design

  • Single center, blinded, randomized control trial
  • N=70
    • Moderate Group (n=32)
    • Deep Group (n=32)
  • Setting: Seoul National University Bundang Hospital
  • Enrollment: September 2013 to April 2014
  • Mean follow-up: 24 hours
  • Analysis: Per protocol
  • Primary outcome: The rate of surgeons increasing the IAP because they deemed the surgical field was inadequate for operation.

Population

Inclusion Criteria

  • 18-69 years of age
  • ASA 2 or 3
  • Elective laparoscopic cholecystectomy

Exclusion Criteria

  • History of neuromuscular, renal, or hepatic disease
  • BMI <18.5 or ≥ 30.0 kg/m2
  • History of abdominal surgery
  • Treatment with drugs known to interfere with neuromuscular function
  • Acute cholecystitis

Baseline Characteristics

  • Deep Group
    • Males (n): 19
    • Females (n): 13
    • Age (median): 45.1 years
    • Weight (mean): 68.2 kg
    • Height (mean): 167.4 cm
    • BMI (mean): 24.1 kg/m2
    • ASA 2: 24
    • ASA 3: 8
    • Diagnosis:
      • Gallbladder Stone: 19
      • Gallbladder Polyp: 7
      • Chronic Cholecystitis: 4
      • Adenomyomatosis of Gallbladder: 2

Interventions

Neuromuscular management and monitoring were performed per the Good Clinical Research Practice guidelines [5].

  • Both Groups
    • IV midazolam 0.002 mg/kg as premedication in the reception area
    • In the OR, routine monitoring with the addition of acceleromyography (TOF-Watch-SX)to monitor the response of the adductor pollicis muscle
    • Induction of anaesthesia with propofol and remifentanil using target controlled infusers
    • TOF-Watch-SX calibrated (series of stable train-of-four measurements) prior to paralysis
    • 0.6 mg/kg of Rocuronium on induction, 5-10 mg boluses after
    • Initial IAP of 8mmHg, increased to 12mmHg at the request of the surgeon
  • Moderate Group
    • Rocuronium boluses to maintain train-of-four count 1 or 2
    • Reversed with Neostigmine/Glycopyrrolate at the end of the procedure
  • Deep Group
    • Rocuronium boluses to maintain a post-tetanic count of 1 or 2
    • Reversed with sugammadex (4mg/kg) at the end of the procedure

Outcomes

Comparisons are deep neuromuscular blockade vs. moderate neuromuscular blockade.

Primary Outcomes

Rate of surgeons increasing the IAP due to inadequate operative field
12.5% vs. 34.4% (P=0.039)

Secondary Outcomes

Intraoperative Patient Movement
1.0% vs. 7.0% (P=0.023)
Mean Amount of Rocuronoim given (mg/kg)
1.0 vs. 0.7 (P<0.001)
Mean Amount of Fentanyl given (μg)
64.0 vs. 57.8 (P=0.480)
Time to Train-of-Four.9 (minutes)
2.5 vs. 6.7 (P<0.001)
Operation Time (minutes)
39.3 vs. 46.8 (P=0.023)
Anesthesia Time (minutes)
67.5 vs. 77.3 (P=0.005)
Mean Postoperative Pain at 30 Minutes (scale of 1-10)
6 vs. 6 (P=0.609)
Mean postoperative Pain at 24 Hours (scale of 1-10)
4 vs. 6 (P=0.048)
Mean Shoulder Tip Pain at 30 Minutes (scale of 1-10)
0 vs. 0 (P=0.609)
Mean Shoulder Tip Pain at 24 Hours (scale of 1-10)
0 vs. 4 (P=0.020)
Postoperative Nausea and Vomiting at 30 Minutes (n)
3 vs. 7 (P=0.168)
Postoperative Nausea and Vomiting at 24 Hours (n)
5 vs. 5 (P=1.00)
Dry Mouth at 30 Minutes (n)
19 vs. 24 (P=0.143)
Dry Mouth at 24 Hours (n)
5 vs. 13 (P=0.026)
Surgeon Ranked Operative View as Excellent or Good
68.8% vs. 34.4% (P=0.001)

Adverse Events

Inappropriate patient movement
3.1% vs. 21.9%

Criticisms

The authors identified the following limitations:

  • Patients with acute cholecystitis excluded
  • Sample size too small to detect differences in secondary outcome variables

Funding

This research was supported by a grant from the Seoul National University Bundang Hospital Research Fund. This project is in compliance with the university's ethical standards. The authors declared no conflicts of interest.

Further Reading

  1. Wallace DH et al. Randomized trial of different insufflation pressures for laparoscopic cholecystectomy. Br J Surg 1997. 84:455-8.
  2. Fuchs-Buder T et al. Sugammadex: clinical development and practical use. Korean J Anesthesiol 2013. 65:495-500.
  3. Sarli L et al. Prospective randomized trial of low-pressure pneumoperitoneum for reduction of shoulder-tip pain following laparoscopy. Br J Surg 2000. 87:1161-5.
  4. Fuchs-Buder T et al. Sugammadex: clinical development and practical use. Korean J Anesthesiol 2013. 65:495-500.
  5. Fuchs-Buder T et al. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand 2007. 51:789-808.