Clinical trial NCT03831815: Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy
Official title: Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Block, Residual
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sexes and who underwent videolaparoscopic cholecystectomy under balanced general anesthesia. ASA (American Society of Anesthesiologists) patients, class I and II, age group of 18 to 50 years, body mass index below 35.

Brief summary: Neuromuscular blockade is essential to provide optimal conditions for tracheal intubation and also to facilitate the performance of surgeries involving mainly the abdominal cavity. The introduction of neuromuscular blockers in clinical practice optimized the execution of mechanical ventilation. Since the use of these drugs, increased intercurrences such as prolonged muscle paralysis and respiratory complications have been observed, resulting in unfavorable outcomes with residual neuromuscular blockade and delayed recurrence due to the occurrence of these complications. The present study aims to evaluate the incidence of residual neuromuscular blockade and late recurarization in the post-anesthetic recovery room in patients submitted to videolaparoscopic cholecystectomy.

Detailed description: This is an observational and prospective study in which patients aged 18-50 years classified as ASA (American Society of Anesthesiologists) I and II, body mass index below 35 and who will undergo cholecystectomy will be included. Patients will be allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participates in the surgery, ie in group C patients will participate in the administration of cisatracurium and the group R will consist of the patients in whom rocuronium was administered. General anesthesia and assessment of muscle function will be performed by measuring the four-stimulus sequence (SQE) / train of four (TOF) at pre-established times. A residual neuromuscular block is considered to be the patient presenting the value of the four-stimulus sequence of T4 / T1 of less than 0.9.

Eligibility criteria: Inclusion Criteria:

* Patients submitted to videolaparoscopic cholecystectomy under balanced general anesthesia. ASA (American Society of Anesthesiologists) patients, class I and II, age group of 18 to 50 years, body mass index below 35.

Exclusion Criteria:

* Patients ASA III or higher; ASA II patients with respiratory comorbidities. Patients with neuromuscular diseases or severe renal or hepatic diseases. Patients submitted to total venous anesthesia. Patients with body temperature below 36 ° C. Replication of the neuromuscular blocker. Use of drugs that accentuate neuromuscular blockade such as calcium channel blockers, inorganic ions (Mg ++, Li ++), aminoglycoside antibiotics, halogenated anesthetics (except sevoflurane), local anesthetics (except lidocaine), benzodiazepines and opioids (except morphine or remifentanil) .

Primary outcomes:
measure: Residual Neuromuscular Blockade
timeFrame: Immediate postoperative period in the post anesthetic recovery room.
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.
state: Minas Gerais
Study officials:
References: