Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study

OhioHealth

Status: Completed

Conditions: Pulmonary Complication; Neuromuscular Blockade

Treatments: Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology

Study type: Observational

Funder types: Other

Identifiers

NCT02984839

16-0047

Details and patient eligibility

About

The aim of this prospective, observational study is to determine the incidence of post-operative residual neuromuscular blockade (PRNB) in patients undergoing intra-abdominal procedures compared to patients undergoing other noncardiac/non intra-thoracic procedures that also require non-depolarizing neuromuscular blocking agents (NMBA) administration. As intra-abdominal surgeries are independently associated with post-operative pulmonary complications (PPCs), it is important to highlight other factors, such as PRNB, that could contribute to these complications.Although it has been shown that the risk of adverse respiratory events can be reduced by intra-operative quantitative neuromuscular monitoring, such monitoring is not in widespread use.This study will incorporate quantitative monitoring in the post-anesthesia care unit (PACU) setting by using the Stimpod NMS450® in an effort to show a disparity in the incidence of residual paralysis between these two patient populations and to emphasize the need to implement more accurate neuromuscular monitoring, especially for those that are already at increased risk for respiratory complications.

Full description

Residual paralysis from non-depolarizing neuromuscular blocking agents (NMBAs) is a common problem that contributes to adverse outcomes in the post-anesthesia care unit (PACU).Unidentified residual neuromuscular blockade (defined as a train-of-four (TOF) ratio <0.9) has been reported in up to 30-42% of patients in the recovery room.Though current literature supports the use of quantitative monitoring of neuromuscular blockade, conventional qualitative TOF count monitoring and clinical signs (head lift, grip strength) continue to be used.There is strong evidence that shows reduction of clinically significant post-operative residual neuromuscular blockade (PRNB) after implementation of quantitative monitoring. Post-operative pulmonary complications (PPCs) are notable adverse outcomes of residual neuromuscular blockade. The implementation of quantitative monitoring may be particularly beneficial to patients who are already predisposed to PPCs secondary to the site of surgery.

The purpose of this study is to evaluate the incidence of PRNB with use of quantitative neuromuscular monitoring in patients undergoing intra-abdominal procedures compared to patients undergoing other surgical procedures that also require NMBA administration.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking

• ASA physical status classification I-IV

• Procedures requiring intubation and nondepolarizing NMBA administration

  • Laparoscopic surgery
  • Intra-abdominal surgery
  • Procedures using the Da Vinci surgical system
  • Tonsillectomy
  • Septoplasty
  • Shoulder surgery
  • Total hip arthroplasty
  • Carotid endarterectomy
  • Cervical spine surgery
  • Parotidectomy
  • Thyroidectomy
  • Aorto-bifemoral bypass
  • Micro laryngoscopy
  • Nasal or sinus surgery
  • Dental extraction

Exclusion criteria

• Non-English speaking population
• ASA V and VI
• Unable to give informed consent
• Cardiac or intra-thoracic procedures performed
• Severe renal insufficiency (Serum Creatinine >2.0 mg/dL)
• Severe hepatic dysfunction
• Underlying neuromuscular disease
• Currently enrolled in another therapeutic study
• Pregnant patients at any stage of pregnancy

Trial design

120 participants in 2 patient groups

Intra-abdominal surgery group

Description:

The study population will include patients presenting for elective or non-elective intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital. Quantitative TOF will be recorded by Stimpod NMS450 in PACU.

Treatment:

Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology

Non-intra-abdominal surgery group

Description:

The study population will include patients presenting for elective or non-elective non intra-abdominal surgery requiring general anesthesia with neuromuscular blockade at OhioHealth Doctors Hospital. Quantitative TOF will be recorded by Stimpod NMS450 in PACU.

Treatment:

Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology