Multi-center Study of Residual Neuromuscular Block Incidence in the Post-anesthesia Care Unit (ReCuSS)
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|ClinicalTrials.gov Identifier: NCT02226809|
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. The incidence is variable due to multiple factors. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action neuromuscular block agents (NMBA).
The main objective is to know the incidence of RNMB in Spanish hospitals. Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
|Condition or disease||Intervention/treatment|
|Incomplete Reversal of Neuromuscular Block Postoperative Respiratory Complications||Device: Accelerometry|
Residual neuromuscular block (RNMB) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. This includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen ICU admissions, and prolonged ICU stays.
The incidence is variable due to multiple factors. Age, gender, surgery, NMBA type and doses, temperature, medications, etc.
In several studies it has been found and incidence between 6-80%. Few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. In Spain the incidence is unknown.
The investigators hypothesize that a number of patients in the postanesthesia care unit (PACU) present with RNMB after general anesthesia using intermediate action NMBA.
The main objective is to know the incidence of RNMB in Spanish hospitals, by means of an observational cross-sectional multicenter study .
Secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.
|Study Type :||Observational|
|Actual Enrollment :||763 participants|
|Official Title:||Incidence of Residual Neuromuscular Block in Adult Patients in the Postanesthesia Care Unit. An Observational Cross-sectional Study of a Multicenter Cohort. The Residual Curarization in Spain Study (ReCuSS).|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Evaluation of RNMB. Application of accelerometry to patients after general anesthesia receiving at least one intermediate action nondepolarizing neuromuscular blocking agent dose
Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU
Other Name: TOF-Watch
- Residual neuromuscular block incidence (TOFr<0.9) measured by accelerometry in the PACU [ Time Frame: Upon arrival to the PACU. Single evaluation. ]
Patients operated on under general anesthesia including intermediate duration NMBA were evaluated by means of an accelerometer in the PACU immediately upon arrival. Train-of-four ratio (TOFr) is evaluated.
The evaluator does'nt know the patient-related information, including intraoperative management.
- Respiratory or airway postoperative complications in the PACU [ Time Frame: During PACU stay, an expected average of 4 hours ]Evaluation of respiratory complications or events in the PACU (asking the anesthesiologist in charge or PACU medical record) to discharge to the ward.
- Relationship of RNMB with preoperative patient related factors [ Time Frame: Upon patients arrival to the PACU ]Analysis of the preoperative visit record and anesthesia record: ASA class, and patient's demographics and characteristics
- Relationship of RNMB with intraoperative anesthesia-related factors [ Time Frame: Upon PACU arrival ]anesthesiologist-in-charge experience, type of anesthesia, intraoperative drugs administered and doses, reversal drugs and doses.
- Relationship of RNMB with surgery-related factors [ Time Frame: Upon PACU arrival ]Relationship of RNMB with surgery related factors (surgical speciality, type of surgery -high risk vs low to intermedium risk, laparoscopic vs no laparoscopic-, duration), blood losses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226809
|Hospital General de Elda|
|Elda, Alicante, Spain, 03600|
|Hospital de Bellvitge|
|Badalona, Barcelona, Spain, 08907|
|Hospital Universitario Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Complejo Hospitalario Universitario|
|A Coruña, Coruña, Spain, 15006|
|Hospital Severo Ochoa|
|Leganés, Madrid, Spain, 28911|
|Hospital de Manacor|
|Manacor, Palma de Mallorca, Spain, 07500|
|Hospital Xeral de Vigo|
|Vigo, Pontevedra, Spain, 36204|
|Hospital Universitario Basurto|
|Basurto, Vizcaya, Spain, 48013|
|Hospital Clinic Universitari|
|Barcelona, Spain, 08036|
|Hospital General de Castellón|
|Castellón, Spain, 12004|
|Hospital Universitario Reina Sofía|
|Córdoba, Spain, 14004|
|Hospital Universitario Virgen de las Nieves|
|Granada, Spain, 18014|
|Hospital San Pedro|
|Logroño, Spain, 26006|
|Hospital Universitario Lucus Augusti|
|Lugo, Spain, 27003|
|Hospital Universitario de la Princesa|
|Madrid, Spain, 28006|
|Hospital General Universitario Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital Ramón y Cajal|
|Madrid, Spain, 28034|
|Hospital Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Hospital Universitario Son Espases|
|Palma de Mallorca, Spain, 07010|
|Hospital Universitario Marqués de Valdecilla|
|Santander, Spain, 39008|
|Hospital Clinico Universitario de Valencia|
|Valencia, Spain, 46010|
|Hospital Arnau de Vilanova|
|Valencia, Spain, 46015|
|Hospital Universitario Dr Peset|
|Valencia, Spain, 46017|
|Hospital Universitario Politécnico La Fe|
|Valencia, Spain, 46026|
|Hospital Miguel Servet|
|Zaragoza, Spain, 50009|
|Principal Investigator:||Carlos L Errando, MD, PhD||Servicio de Anestesiologia. Consorcio Hospital General Universitario de Valencia|
|Principal Investigator:||Ignacio Garutti, MD, PhD||Servicio de Anestesiologia. Hospital Universitario Gregorio Marañon|