Anesthesia, General Clinical Trial
Official title:
Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System: a Randomized Controlled Trial.
Closed loop system in intravenous anesthesia is more effective to maintain depth of
anesthesia compared with manual system open, it is unclear what driver and variables to
achieve this goal be more physiological; in the literature doesn´t exist studies showing
that the closed-loop system for both hypnotic and opioid is better than the controlled
pharmacokinetic models and open loop system (target controlled infusion-TCI) to maintain
anesthetic depth. In addition, the infusion of the opioid lacks physiological controllers in
closed loop. Thus, a system was designed for intravenous anesthesia in closed loop for
propofol as hypnotic based on neuromonitoring bispectral index as anesthetic depth, and was
integrated an additional closed system for remifentanil using hemodynamic variables and
control algorithm associated with bispectral index.
The purpose of this study is to determine the therapeutic effectiveness of a new system of
administration of intravenous anesthesia in closed loop to maintain a depth of anesthesia
compared to an open loop system TCI.
Status | Completed |
Enrollment | 150 |
Est. completion date | April 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Older than 18 years - Scheduled for noncardiac surgery elective low-risk or intermediate - Expected surgery time greater than 1 hour - Procedure requiring general anesthesia - Classification of the American Society of Anesthesiologists (ASA) as I or II Exclusion Criteria: - Pregnant women - Surgery scheduled urgent or emergency - Personal history of allergy to eggs or any other part of propofol - Personal history of abnormalities or congenital or acquired cognitive sequels: infantile cerebral palsy, Down syndrome, cerebral ischemic disease, traumatic brain injury, brain tumor, autism. - Chronic use of benzodiazepines or antipsychotics - A patient who does not consent to participate in the study prior to surgery or before randomization - Need for anesthetic or analgesic blockade before surgery peripheral nerve |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Hospital Universitario San Vicente Fundación | Medellin | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia |
Colombia,
Carregal A, Lorenzo A, Taboada JA, Barreiro JL. [Intraoperative control of mean arterial pressure and heart rate with alfentanyl with fuzzy logic]. Rev Esp Anestesiol Reanim. 2000 Mar;47(3):108-13. Spanish. — View Citation
De Smet T, Struys MM, Neckebroek MM, Van den Hauwe K, Bonte S, Mortier EP. The accuracy and clinical feasibility of a new bayesian-based closed-loop control system for propofol administration using the bispectral index as a controlled variable. Anesth Ana — View Citation
Hemmerling TM, Arbeid E, Wehbe M, Cyr S, Taddei R, Zaouter C. Evaluation of a novel closed-loop total intravenous anaesthesia drug delivery system: a randomized controlled trial. Br J Anaesth. 2013 Jun;110(6):1031-9. doi: 10.1093/bja/aet001. Epub 2013 Feb — View Citation
Janda M, Simanski O, Bajorat J, Pohl B, Noeldge-Schomburg GF, Hofmockel R. Clinical evaluation of a simultaneous closed-loop anaesthesia control system for depth of anaesthesia and neuromuscular blockade*. Anaesthesia. 2011 Dec;66(12):1112-20. doi: 10.111 — View Citation
Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun; — View Citation
Ngan Kee WD, Khaw KS, Ng FF, Tam YH. Randomized comparison of closed-loop feedback computer-controlled with manual-controlled infusion of phenylephrine for maintaining arterial pressure during spinal anaesthesia for caesarean delivery. Br J Anaesth. 2013 — View Citation
Puri GD, Kumar B, Aveek J. Closed-loop anaesthesia delivery system (CLADS) using bispectral index: a performance assessment study. Anaesth Intensive Care. 2007 Jun;35(3):357-62. — View Citation
Sakai T, Matsuki A, White PF, Giesecke AH. Use of an EEG-bispectral closed-loop delivery system for administering propofol. Acta Anaesthesiol Scand. 2000 Sep;44(8):1007-10. — View Citation
Struys MM, De Smet T, Versichelen LF, Van De Velde S, Van den Broecke R, Mortier EP. Comparison of closed-loop controlled administration of propofol using Bispectral Index as the controlled variable versus "standard practice" controlled administration. An — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time in adequate anesthetic depth | Difference in therapeutic effectiveness determined by the time in state suitable anesthetic depth. The proper anesthetic depth is defined as the efficacy to maintain a Bispectral Index in the range of 40 - 60 during a surgery. | intraoperative | No |
Secondary | Proportion of patients with adequate anesthetic depth | Difference in the proportion of patients with adequate depth of anesthesia. Anesthetic depth is defined as appropriate when the percentage of time the patient spends in this range (BIS between 40 and 60) is greater than 80%. | intraoperative | No |
Secondary | Difference in technical performance drivers intravenous infusion | The performance will be determined using methods Varvel et al. Performance error (PE) is defined as the difference between the actual value and the target value. Median performance error (MDPE) and Error Performance Absolute Median (MDAPE) as measures of validity and accuracy, respectively. Wobble as a measure of variability in performance error. | intraoperative | No |
Secondary | Difference in the proportion of patients with adequate intraoperative analgesia | Difference in the proportion of patients with adequate analgesia intraoperative defined according to the values of "analgoscore", a scale for the measurement of intraoperative pain developed and validated by Hemmerling et al. It is based on measuring the averagely nociception determined mean arterial pressure and heart rate, which generates a numerical range between -9 and 9. A value between -3 and +3 represents excellent pain control; a value between -6 to -3 and +3 to +6 indicates good pain control;-6 To -9 and +9 +6 it indicates inadequate pain control. Adequate intraoperative analgesia is considered when the percentage of time the patient spends in the range of values between - 6 and +6 is greater than 80%. | intraoperative | No |
Secondary | Difference in the proportion of patients in which they have to perform manual modification of the drug infusion. | Any manual handling of the anesthesia system is considered one that performs different from the initial programming output. | intraoperative | No |
Secondary | Difference in the rate of change of an intravenous anesthetic technique to a technique based on halogenated. | intraoperative | No | |
Secondary | Amount of anesthetic medications used during the anesthetic | intraoperative | No | |
Secondary | Proportion of patients with haemodynamic instability. | Hemodynamic instability any of the following events are considered: Reduction of more than 20% of the basal MAP and HR increased more than 10% of baseline; Decreased heart rate less than 10% increase in MAP and more than 5%; Need for vasopressor support with bolus or continuous infusion of drugs alpha and / or beta-agonists; Parasympatholytic need. | intraoperative | Yes |
Secondary | Proportion of patients with intraoperative recall | Difference in the proportion of patients with intraoperative recall. Intraoperative recall will be measured with a validated scale as Michigan scale, which ranks intraoperative recall in 6 classes: Class 0, where there are no symptoms of memory; Class 1, isolated auditory perceptions; Class 2, tactile perceptions, such as surgical manipulation or endotracheal intubation; Class 3, Pain; Class 4, paralysis defined as the feeling of being unable to move, speak or breathe; Class 5, paralysis and pain. If any of these classes is associated with negative emotional impact (fear, anxiety, suffocation feeling of death, etc.) will be added to the letter D | 2 hours after surgery | Yes |
Secondary | Proportion of patients with awakening during anesthetic maintenance | It will be as any episode of patient movement during surgical painful stimulus including upper, lower or respiratory system (cough reflex to the presence of the endotracheal tube) extremities. | intraoperative | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06063798 -
Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
|
N/A | |
Not yet recruiting |
NCT05035069 -
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
|
Phase 4 | |
Completed |
NCT03861364 -
Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
|
Phase 4 | |
Completed |
NCT02711280 -
The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children
|
N/A | |
Completed |
NCT01199471 -
Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane
|
N/A | |
Completed |
NCT00917033 -
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy
|
Phase 4 | |
Completed |
NCT00391885 -
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy
|
Phase 4 | |
Completed |
NCT00552617 -
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
|
Phase 2 | |
Completed |
NCT03705026 -
Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
|
||
Completed |
NCT00552929 -
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)
|
Phase 2 | |
Completed |
NCT00298831 -
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
|
Phase 3 | |
Completed |
NCT00475215 -
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
|
Phase 3 | |
Recruiting |
NCT03943745 -
EEG Changes During Induction of Propofol Anesthesia
|
||
Completed |
NCT03697642 -
Nasopharyngeal Airway Guide Nasogastric Tube Placement
|
N/A | |
Completed |
NCT04595591 -
Observation of Propofol Titration at Different Speeds
|
N/A | |
Not yet recruiting |
NCT05841316 -
The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
|
||
Completed |
NCT04532502 -
Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
|
||
Completed |
NCT03330236 -
EEG - Guided Anesthetic Care and Postoperative Delirium
|
N/A | |
Recruiting |
NCT06205212 -
High-flow Nasal Oxygenation During Preoxygenation and Atelectasis
|
N/A | |
Completed |
NCT00379613 -
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)
|
Phase 2 |