Neuromuscular Block, ResidualNCT03831815
Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy
An observational study of Neuromuscular Block, Residual, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Block, Residual
- What is being tested?
- Cisatracurium
- How many people
- 85 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Nov 2017to 18 May 2018
- How long will I take part?
- 7 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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) .
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Minas Gerais, Faculdade de Medicina, Departamento de Cirurgia.
Belo Horizonte, Minas Gerais, 30130100
About this study
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.
Read the 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
- Being tested
- Cisatracurium
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisatracuriumDrug
Also called Rocuronium
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate postoperative period in the post anesthetic recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start3 Nov 2017
- Primary completion18 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Block, ResidualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831815
- Sponsor's protocol ID
- CAAE: 71086417.3.0000.5121
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03831815
- Acronym / sponsor ID
- CAAE: 71086417.3.0000.5121
- Conditions
- Neuromuscular Block, Residual
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grupo C: cisatracurium | – | Drug: CisatracuriumPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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) .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisatracuriumAlso: RocuroniumPatients 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. | Drug | Grupo C: cisatracurium |
Primary outcome
Residual Neuromuscular Blockade
Time frame: Immediate postoperative period in the post anesthetic recovery room.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Block, Residual, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Neuromuscular Blockade (time frame: Immediate postoperative period in the post anesthetic recovery room.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.