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

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade; Pulmonary Complication
• Intervention / Treatment: Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43228
      • OhioHealth Doctors Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all patients age 18 or older with American Society of Anesthesiologists (ASA) physical status I-IV presenting for elective or non-elective surgery requiring general anesthesia with neuromuscular blockade.While previous studies have found that up to 30-42% of patients experience PRNB in the PACU, no previous studies have estimated the incidence of PRNB by surgical procedure (i.e., intra-abdominal versus other surgical procedures).Therefore, this study will be more descriptive in nature.A difference of at least 10% in the incidence of PRNB between the two groups will be considered clinically significant.A maximum number of 120 (approximately 60 patients who undergo intra-abdominal surgery and 60 patients who undergo non intra-abdominal surgical procedures) will be enrolled during the course of the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intra-abdominal surgery group; 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.	Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology; Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450
Non-intra-abdominal surgery group; 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.	Device: Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology; Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Train-of-four (TOF) ratio	Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU	15 minutes post arrival in the post anesthesia care unit (PACU)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for supplemental O2 therapy	Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication	30 minutes post arrival in the PACU

Collaborators and Investigators

• Sponsor: OhioHealth
• Investigators: Principal Investigator: Kayla Petersen, D.O., Resident Physician

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 21, 2017
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: December 3, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: intra-abdominal surgery; neuromuscular blocking agent; post-anesthesia care unit
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Delayed Emergence from Anesthesia
• Other Study ID Numbers: 16-0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No