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

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ClinicalTrials.gov Identifier: NCT02984839
Recruitment Status : Active, not recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Kayla Petersen, OhioHealth

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.

Condition or disease Intervention/treatment
Neuromuscular Blockade Pulmonary Complication 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
Estimated Enrollment : 120 participants
Time Perspective: Cross-Sectional
Official Title: Incidence of Residual Neuromuscular Blockade in Intra-abdominal Surgery: A Prospective, Observational Study
Study Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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




Primary Outcome Measures :
  1. Train-of-four (TOF) ratio [ Time Frame: 15 minutes post arrival in the post anesthesia care unit (PACU) ]
    Average TOF ratio will be calculated from two consecutive readings using the Stimpod NMS450 within 15 minutes of arrival in the PACU


Secondary Outcome Measures :
  1. Need for supplemental O2 therapy [ Time Frame: 30 minutes post arrival in the PACU ]
    Necessity for supplemental O2 therapy after 30 minutes in PACU will be recorded via chart review to determine post operative pulmonary complication



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984839


Locations
United States, Ohio
OhioHealth Doctors Hospital
Columbus, Ohio, United States, 43228
Sponsors and Collaborators
OhioHealth
Investigators
Principal Investigator: Kayla Petersen, D.O. Resident Physician

Responsible Party: Kayla Petersen, Resident Physician, OhioHealth
ClinicalTrials.gov Identifier: NCT02984839     History of Changes
Other Study ID Numbers: 16-0047
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kayla Petersen, OhioHealth:
intra-abdominal surgery
neuromuscular blocking agent
post-anesthesia care unit

Additional relevant MeSH terms:
Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs