Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy

NCT03831815 | Completed DMC FDA Drug

• 1 other identifier: CAAE: 71086417.3.0000.5121
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Block, Residual

Outcome Measures

Primary Outcomes (1)

• Residual Neuromuscular Blockade

  The patient who presented the value of the sequence of four T4 / T1 stimuli of less than 0.9 was considered to have residual neuromuscular block.

  Immediate postoperative period in the post anesthetic recovery room.

Study Arms (2)

Grupo C: cisatracurium

Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participated in the surgery. In group C, patients received cisatracurium and in group R, rocuronium was administered to patients.

Drug: Cisatracurium

Grupo R: rocuronium

Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participated in the surgery. In group C, patients received cisatracurium and in group R, rocuronium was administered to patients.

Interventions

Cisatracurium DRUG

Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist participating in the surgery. In group C, the patients in whom cisatracurium was given and the R group consisted of the patients in whom rocuronium was administered. It is emphasized that the choice of the neuromuscular blocker was made by the preference and experience of the anesthesiologist of the case and not by randomization or lottery of the patients.

Also known as: Rocuronium

Grupo C: cisatracurium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

cisatracurium; Rocuronium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: November 3, 2017
• Primary Completion: May 18, 2018
• Study Completion: May 18, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

BR (1)