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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984839
• Other study ID #: 16-0047
• Status: Completed
• Start date: November 2016
• Est. completion date: May 16, 2017

Study information

• Verified date: July 2018
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 16, 2017
• Est. primary completion date: March 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade
• Pulmonary Complication

Intervention

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

Locations

Country	Name	City	State
United States	OhioHealth Doctors Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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