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Anesthesia, General clinical trials

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NCT ID: NCT06331611 Not yet recruiting - Clinical trials for Neuromuscular Blockade

MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA

MOTOR
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

To date there is still little scientific evidence regarding neuromuscular block monitoring in pediatric anesthesia and indications for safe reversal. Although the use of rocuronium and sugammadex is becoming wide, qualitative monitoring or clinical practice are applied instead of quantitative monitoring (acceleromyography-electromyography EMG). The use of neuromuscular monitoring leads to better control of intraoperative paralysis, proper timing of extubation, and reduced risk of residual postoperative paralysis-paralysis (PORC) and related complications. The main objective of the study is to analyse the incidence of sugammadex use and the total dose/kg, with and without the aid of quantitative neuromuscular monitoring. Secondary objectives are: - the time required to extubate different patients, - the incidence of respiratory complications at extubation, - the need to administer additional doses of sugammadex. A prospective RCT. Patients will be divided into two study groups; in the first group, quantitative neuromuscular monitoring based on electromyography (EMG) will be used, while in the second group, the same monitoring will be applied but covered (blinded to the anesthetist) and the pharmacological strategy is based exclusively on the clinical practice All children aged between 2 months and 6 years, scheduled to undergo elective non-cardiac surgical procedures, lasting approximately from one to two hours(anesthesia time), with general anesthesia and tracheal intubation receiving a non-depolarizing blockade agent. - Children between 2 months and 6 years - Children who will undergo elective non cardiac surgery (maximum two hours of anesthesia time with tracheal intubation receiving a non depolarizing blockade agent), - Acquisition of informed consent by a legally recognized representative capable of understanding the document and providing consent on behalf of the participant. - Children under 2 months of age or over 12 years of age, - Children with an ASA classification > 3, - Presence of neuromuscular disease, channelopathy, or any clinical condition that contraindicates the administration of neuromuscular muscle relaxants, - Confirmed or suspected allergy to sugammadex or rocuroniumt, - Presence of amputation or limb malformations that make placement of neuromuscular monitoring impossible, - Any specific contraindication to any aspect of the protocol. 12 months The randomization process will performed using numbers randomized by a computer-generated random number sequence. The randomization list will be prepared by independent statistician . The subjects will be assigned to the treatment arm in a sequence as per the randomization code provided in a closed envelope in a 1:1 ratio. The investigator will administered the treatment as per the randomization codes. One hundred children undergo in the clinically guided group and 100 children in the neuromuscular monitoring groups with the aim to include 200 children in total. Demographics and baseline characteristics with mean, median, standard deviation, and range (minimum, maximum) will generated for each arm. Subject disposition, including the number of subjects withdrawn or discontinued from the study, for each arm will summarized. The study will follow the CONSORT guidelines for statistical analysis and reporting. Chi squared test or Fisher's exact test and Student's t-test or Mann Whitney test will applied to categorical and continuous data, respectively, with a significance level of 5% by two-sided test. Statistical analysis was performed using SPSS software (ver. 21.0) (IBM, Armonk, NY, USA).

NCT ID: NCT06283914 Not yet recruiting - Clinical trials for Respiratory Distress Syndrome

Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry

Start date: March 1, 2024
Phase:
Study type: Observational

The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT. The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age >18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded.

NCT ID: NCT06220136 Not yet recruiting - Clinical trials for Neuromuscular Blockade

Comparison of the Performances of the cTOFR and the mTOFR During Reversal of Deep Neuromuscular Blockade With Sugammadex

Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

It is known that deep neuromuscular block improves surgical conditions, especially during laparoscopic abdominal surgery. Based on this, in the Perioperative Neuromuscular Blockade Management guide published by the ESAIC association in 2022, it is recommended to deepen the level of neuromuscular blockade in cases where surgical conditions need to be improved. Sugammadex should be used to quickly and reliably reverse deep neuromuscular blockade. TOFScan, a 3-dimensional acceleromyograph for neuromuscular monitoring, has become widely used in recent years. With this monitor, it has been shown that in addition to the classical train-of-four ratio (cTOFR), the modified train-of-four ratio (mTOFR) can be used during the spontaneous recovery of nondepolarizing neuromuscular blockade. In a study conducted by Schmartz et al. in 2021, it was shown that mTOFR, which is the ratio of T4 to the reference stimulus, was compiled later than cTOFR. Therefore, it is suggested that the mTOFR value is a better determinant for safe extubation.

NCT ID: NCT06205212 Recruiting - Anesthesia, General Clinical Trials

High-flow Nasal Oxygenation During Preoxygenation and Atelectasis

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.

NCT ID: NCT06150001 Not yet recruiting - Anesthesia, General Clinical Trials

Reduction of Rocuronium-induced Injection Pain With Aspiration of Blood

Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. The main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. Rocuronium is a rapid onset muscle relaxant used in general anesthesia. Lidocaine is a local anesthetic. Researchers will • inject diluted rocuronium in participant's intravenous catheter during induction. • record withdrawal movement and rocuronium onset time and duration measured by train-of-four (TOF). Researchers will compare between rocuronium diluted with blood, lidocaine and normal saline to see if blood can reduce rocuronium injection pain.

NCT ID: NCT06107998 Completed - Anesthesia, General Clinical Trials

Comparison of Different Methods for Determining Endotracheal Cuff Pressure

Start date: November 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether the stethoscope can be used as a method of assessing endotracheal cuff pressure as effectively as a manometer and also to compare it with the balloon palpation/audible leak method frequently used in clinical practice in adult patients undergoing general anesthesia. The main questions it aims to answer are: - Is the stethoscope as effective as a manometer in assessing endotracheal cuff pressure? - Is there a difference between stethoscope and audible leak/balloon palpation methods in assessing endotracheal cuff pressure? Participants will be randomly divided into 2 groups. - Group P: After intubation, endotracheal cuff pressure will be assessed by audible leak/balloon palpation. - Group S: After intubation, endotracheal cuff pressure will be assessed with a stethoscope. - Control will be carried out with a manometer and the pressure values obtained in the groups will be corrected. Researchers will compare ''stethoscope'' and ''audible leak/balloon palpation'' groups to see if which method is effective like a manometer.

NCT ID: NCT06063798 Recruiting - Anesthesia, General Clinical Trials

Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery

Flowjet
Start date: September 5, 2023
Phase: N/A
Study type: Interventional

Laryngotracheal surgery often requires a small diameter endotracheal tube to oxygenate patients under general anesthesia. Oxygenation is often only possible with high-frequency jet ventilators due to the use of small diameter and high resistance airway cannulas. Flow controlled ventilation is a new ventilation modality capable for ventilation through a small diameter endotracheal tube (Tritube) with an active expiratory phase and the possibility of controlled carbon dioxide elimination during mechanical ventilation. The aim of the present trial is to characterize perioperative changes in lung volume, ventilation inhomogeneity and respiratory mechanics in patients undergo upper airway surgery under general anesthesia with either flow controlled or high-frequency jet ventilation.

NCT ID: NCT06026033 Completed - Anesthesia, General Clinical Trials

The Effect of Anthropometrics on Desflurane Rise Time

Start date: February 1, 2022
Phase:
Study type: Observational

Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are known and its distribution is easily modeled. Yet these models fail in practice. In order to increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar dead space, all of which are either hard to measure or impractical, at least. A previous study performed by the same investigator showed that time to target endtidal concentration of sevoflurane is prolonged with increased cardiac output, but only if the patient has increased muscle mass. Although desflurane has lower muscle and fat solubility, our observations suggest a similar prolongation in case of increased muscle mass. The investigators aim to investigate if patient characteristics such as gender, age, height, weight, body type prolongs time to reach target endtidal desflurane concentration in low flow anesthesia.

NCT ID: NCT06002568 Not yet recruiting - Anesthesia, General Clinical Trials

Effect of Binaural Beats for Maintenance of General Anesthesia

BB
Start date: August 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the effects of binaural beats on maintenance of general anesthesia in patients undergoing thyroidectomy without intraoperative neuromonitoring. The main question it aims to answer is: - 1) Does applying binaural beats during surgery reduce the gas anesthetics (especially sevoflurane) requirement to maintaining adequate anesthetic depth during general anesthesia? - 2) Does applying binaural beats during surgery affect intraoperative hemodynamic stability or post operative nausea and vomiting? Participants will wear headsets with a sound generator which contains music files (binaural beat file in the intervention group (BB) ; silent file in control group (C)) according to the randomization. Researchers will compare the BB and C group to see if intraoperative binaural beats reduce the requirements of sevoflurane for maintaining adequate anesthetic depth.

NCT ID: NCT05906225 Not yet recruiting - Anesthesia, General Clinical Trials

Anesthesia and EEG Discontinuity in Infants

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.