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Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric Patients

2014-07-23 21:11:12 | BioPortfolio

Summary

The objective of the study is to determine wether the use of the Bispectral Index Monitor (BIS) as a method to guide anaesthesia for children in different groups of age, undergoing ear nose and throat surgery anaesthetized with an infusion of Propofol and Remifentanil with an high dose of Remifentanil (0,5-2 mcg/kg/min), can lead to a reduction in the time needed for extubation and in the amount of anesthetics used.

Description

The participants to the study are patients undergoing the following operations: Tonsillectomy, Adenoidectomy, Microlaryngoscopy, Bronchoscopy, Esophagoscopy, Myringoplastic, Myringotomy with positioning of a tube.

All these procedures are performed with the patient receiving a general anesthesia with and infusion of Propofol and Remifentanil. Muscle relaxants and inhaled anesthetics are not used.

The patients undergoing a Tonsillectomy will receive a supplementary opioid analgesic (Inj. Fentanyl iv, 3mcg/kg) at the end of the surgical procedure. Patients undergoing the other operations receive intraoperative Paracetamol and NSAID for postoperative pain treatment.

Stratification by age (1-3y, 4-11y, 12-17y, 18-65y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects. Stratification by operation type will be performed to ensure the identification of the effects of the duration of anaesthesia and of the use of longer acting opioids (Fentanyl) on outcome parameters.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Anesthesia, General

Intervention

Propofol, Remifentanil, Bispectral Index Monitor

Location

Aalborg Hospital, 4th. dept of Anaesthesiology, Division for Ear Nose and Troath anaesthesia
Aalborg
Nord Jylland
Denmark
9800

Status

Recruiting

Source

Aalborg Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:12-0400

Clinical Trials [1965 Associated Clinical Trials listed on BioPortfolio]

Composite Variability Index Versus Bispectral Index (BIS)

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifent...

Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.

Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.

Evaluation of a Novel Closed-loop Propofol and Remifentanil System Guided by Bispectral Index Compared to a TCI Open-loop System

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 goa...

The Comparability of Bispectral Index and Neurosense During Anesthesia

The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroen...

Use of Closed-loop Anesthesia in Pediatric Patients

To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia

PubMed Articles [10514 Associated PubMed Articles listed on BioPortfolio]

Prediction of Bispectral Index during Target-controlled Infusion of Propofol and Remifentanil: A Deep Learning Approach.

The discrepancy between predicted effect-site concentration and measured bispectral index is problematic during intravenous anesthesia with target-controlled infusion of propofol and remifentanil. We ...

Nociceptive stimulation during Macintosh direct laryngoscopy compared with McGrath Mac videolaryngoscopy: A randomized trial using indirect evaluation using an automated administration of propofol and remifentanil.

Decrease of the nociceptive stimulation induced by laryngoscopy could be an advantage for patients without risk of difficult intubation. The present study aimed to compare the difference in nociceptiv...

Safety of Monitored Anesthesia Care Using Propofol-Based Sedation for Pleuroscopy.

The optimal approach to sedation for pleuroscopy remains undefined. Propofol is the favored sedative-hypnotic for many proceduralists but has a narrow therapeutic window and the risk for oversedation ...

Prevalence of discordant elevations of state entropy and bispectral index in patients at amnestic sevoflurane concentrations: a historical cohort study.

Processed electroencephalogram (EEG) monitors help assess the hypnotic state during general anesthesia or sedation. Maintaining the bispectral index (BIS) or state entropy (SE) between 40 and 60 has b...

Perioperative incidence of airway obstructive and hypoxemic events in patients with confirmed or suspected sleep apnea - a prospective, randomized pilot study comparing propofol/remifentanil and sevoflurane/remifentanil anesthesia.

Obstructive sleep apnea (OSA) is a risk factor for perioperative complications but data on anesthesia regimen are scarce.

Medical and Biotech [MESH] Definitions

Abnormally slow pace of regaining CONSCIOUSNESS after general anesthesia (ANESTHESIA, GENERAL) usually given during surgical procedures. This condition is characterized by persistent somnolence.

An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.

Rare and often fatal drug complication which affects patients undergoing long-term treatment with high doses of PROPOFOL. It is characterized by METABOLIC ACIDOSIS; HYPERLIPIDEMIA; RHABDOMYOLYSIS; cardiovascular CIRCULATORY COLLAPSE; CARDIAC FAILURE; and KIDNEY FAILURE.

The period of emergence from general anesthesia, where different elements of consciousness return at different rates.

A barbiturate that is administered intravenously for the production of complete anesthesia of short duration, for the induction of general anesthesia, or for inducing a hypnotic state. (From Martindale, The Extra Pharmacopoeia, 30th ed, p919)

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