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

NCT02984839 | Completed

• 1 other identifier: 16-0047
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blockade; Pulmonary Complication

Keywords

intra-abdominal surgery; neuromuscular blocking agent; post-anesthesia care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need for supplemental O2 therapy

  30 minutes post arrival in the PACU

Study Arms (2)

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

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

Interventions

Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology DEVICE

Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450

Intra-abdominal surgery group; Non-intra-abdominal surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OhioHealth: lead

Study Sites (1)

OhioHealth Doctors Hospital

Columbus, Ohio, 43228, United States

Location

Study Officials

• Kayla Petersen, D.O.

  Resident Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2016
• Primary Completion: March 21, 2017
• Study Completion: May 16, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)