Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-01

Brief Summary

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The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).

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Detailed Description

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Conditions

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Neuromuscular Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Group

Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Deep NMB group

Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Reversal of deep neuromuscular block

Rocuronium

Intervention Type DRUG

Maintenance of deep neuromuscular block

Interventions

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Sugammadex

Reversal of deep neuromuscular block

Intervention Type DRUG

Rocuronium

Maintenance of deep neuromuscular block

Intervention Type DRUG

Other Intervention Names

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Org 25969 Bridion Zemuron Esmeron

Eligibility Criteria

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Inclusion Criteria

* Patients ASA I-III
* Between 18 - 80 years old
* Scheduled for routine cervical surgery
* Minimum duration of surgery is 90 minutes and performed with total intravenous anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the neuromuscular relaxant rocuronium
* Patients that are able to and do provide a signed informed consent form

Exclusion Criteria

* Patients with neuromuscular diseases and severe cardiac and respiratory pathologies
* Contra indication for any of the drugs used
* Not able to complete the baseline PQRS test.
* Indication to perform tracheal intubation using fibroscopy
* Patients who are pregnant or nursing

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No