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

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

Sponsors

Lead Sponsor: Federal University of Minas Gerais

Source Federal University of Minas Gerais
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.

Overall Status Completed
Start Date 2017-11-03
Completion Date 2018-05-18
Primary Completion Date 2018-05-18
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Residual Neuromuscular Blockade Immediate postoperative period in the post anesthetic recovery room.
Enrollment 85
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cisatracurium

Description: 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.

Arm Group Label: Grupo C: cisatracurium

Other Name: Rocuronium

Eligibility

Sampling Method: Non-Probability Sample

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) .

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.
Location Countries

Brazil

Verification Date

2019-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Federal University of Minas Gerais

Investigator Full Name: Renato Santiago Gomez

Investigator Title: Doctor

Has Expanded Access No
Condition Browse
Arm Group

Label: Grupo C: cisatracurium

Description: 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.

Label: Grupo R: rocuronium

Description: 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.

Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov

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