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

NCT ID: NCT03831815

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2018-05-18

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.

Conditions

Neuromuscular Block, Residual

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cisatracurium

Intervention Type: 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.

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.

No interventions assigned to this group

Interventions

Cisatracurium

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.

Intervention Type: DRUG

Other Intervention Names

Rocuronium

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) .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Renato Santiago Gomez

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

CAAE: 71086417.3.0000.5121

Identifier Type: -

Identifier Source: org_study_id