Neostigmine Reversal And Neuromuscular Recovery

NCT02433808 | Completed Phase 4

• 1 other identifier: EH15-089
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing surgery often receive paralytic agents (or neuromuscular blocking agents (NMBAs)) to facilitate the procedure. At the end of surgery, the effects NMBAs are reversed with a drug called neostigmine. The use of neostigmine significantly reduces the risk that a patient will be left with muscle weakness in the recovery room. Many anesthesiologists routinely use neostigmine because postoperative muscle weakness may lead to adverse events after surgery. Other anesthesiologists do not routinely administer neostigmine in the operating room because of concerns about potential side effects. Surprisingly, some investigators have reported that neostigmine-induced muscle weakness may occur if the drug is given when the effects of the NMBAs have completely worn off. In contrast, other investigators have not observed this side effect when neostigmine was given at the end of surgery. The aim of this study is to determine whether neostigmine use is associated with muscle weakness when it is given at the time of nearly complete recovery from NMBAs. Muscle strength will be measured using a sensitive monitor (TOF-Watch-SX) and through an examination of the patient for evidence of muscle weakness. Patients will also be evaluated how they recover from anesthesia and surgery.

Conditions

Residual Neuromuscular Block

Outcome Measures

Primary Outcomes (1)

• Change in train-of-four (TOF) ratio

  The effect of neostigmine or placebo (saline) on TOF ratios, when given at full neuromuscular recovery, will be assessed

  30 minutes after the end of the surgical procedure

Secondary Outcomes (2)

• airway obstruction-presence or absence (yes or no)

  30 minutes after the end of the surgical procedure

• hypoxemic events (oxygen saturation by pulse oximeter (SpO2) < 94%)

  30 minutes after the end of the surgical procedure

Study Arms (2)

Neostigmine Group

EXPERIMENTAL

Neostigmine will be administered at the conclusion of the surgical procedure

Drug: Neostigmine Group

No Neostigmine group

PLACEBO COMPARATOR

Saline will be administered at the conclusion of the surgical procedure

Other: No Neostigmine group

Interventions

Neostigmine Group DRUG

Neostigmine will be used to reverse neuromuscular block at the conclusion of the surgical procedure. The effect on muscle strength will be determined using the TOF-Watch-SX and clinical examination

Neostigmine Group

No Neostigmine group OTHER

Saline will be administered to patients at the end of the surgical procedure when neuromuscular function has recovered

Also known as: Placebo Comparator

No Neostigmine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages of 18-80
• Patients undergoing general anesthesia requiring endotracheal intubation
• Procedures that do not require maintenance of neuromuscular blockade for completion of the surgical procedure

You may not qualify if:

• Presence of renal failure (creatinine \> 2.0 mg/dL)
• Neuromuscular disease impacting upper airway musculature or neuromuscular monitoring
• Lack of access to either upper extremity for monitoring
• Procedure duration less than 30 minutes
• Requirement for postoperative intubation
• Patients not achieving a TOF ratio of ≥ 0.9 at the end of surgery will be excluded from either study cohort.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

US (1)