Dose conversion and titration with a novel, once-daily, OROS osmotic technology, extended-release hydromorphone formulation in the treatment of chronic malignant or nonmalignant pain.

The objective of this open-label, repeated-dose, single-treatment, multicenter study was to evaluate the outcomes associated with a standardized conversion from prior opioid therapy to a novel, once-daily, OROS osmotic technology, extended-release (ER) hydromorphone formulation in an outpatient population with chronic malignant or nonmalignant pain. The study period was divided into 3 phases: the prior opioid stabilization phase (> or =3 days), the conversion and titration phase (3-21 days), and the maintenance phase (14 days). Patients were evaluated at 5 visits during the study period.

Dose-response effect of combination hydrocodone with ibuprofen in patients with moderate to severe postoperative pain.

Objective: The objective of this study was to demonstrate a dose-response effect with 1- and 2-tablet doses of combination hydrocodone 7.5 mg with ibuprofen 200 mg and placebo in patients with moderate to severe postoperative abdominal or gynecologic pain.

Background: Hydrocodone 7.

Combination hydrocodone and ibuprofen versus combination codeine and acetaminophen for the treatment of chronic pain.

Objective: The objective of this study was to compare the effectiveness of combination hydrocodone 7.5 mg and ibuprofen 200 mg with that of combination codeine 30 mg and acetaminophen 300 mg for the treatment of chronic pain.

Background: Hydrocodone 7.

Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain.

Objective: The objective of this study was to compare the effectiveness of combination hydrocodone and ibuprofen with that of combination oxycodone and acetaminophen in the treatment of moderate to severe postoperative obstetric or gynecologic pain.

Background: Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen.

Safety of withdrawing inhaled nitric oxide therapy in persistent pulmonary hypertension of the newborn.

Objective: Because of case reports describing hypoxemia on withdrawal of inhaled nitric oxide (I-NO), we prospectively examined this safety issue in newborns with persistent pulmonary hypertension who were classified as treatment successes or failures during a course of I-NO therapy.

Methods: Randomized, placebo-controlled, double-masked, dose-response clinical trial at 25 tertiary centers from April 1994 to June 1996. Change in oxygenation and outcome (death and/or extracorporeal membrane oxygenation) during or immediately after withdrawing I-NO were the principal endpoints.

Desflurane and isoflurane produce similar alterations in systemic and pulmonary hemodynamics and arterial oxygenation in patients undergoing one-lung ventilation during thoracotomy.

Unlabelled: We tested the hypothesis that desflurane (DES) and isoflurane (ISO) produce similar effects on systemic and pulmonary hemodynamics and arterial oxygenation before, during, and after one-lung ventilation (OLV) in patients undergoing thoracotomy. After obtaining informed consent, anesthesia was induced with sodium thiopental or thiamylal, fentanyl, and vecuronium in 61 ASA physical status II-IV patients. Patients were randomly assigned to receive either DES (n = 30) or ISO (n = 31) in 100% O2 in separate groups.

Inhaled nitric oxide for the early treatment of persistent pulmonary hypertension of the term newborn: a randomized, double-masked, placebo-controlled, dose-response, multicenter study. The I-NO/PPHN Study Group.

Objectives: To assess the dose-related effects of inhaled nitric oxide (I-NO) as a specific adjunct to early conventional therapy for term infants with persistent pulmonary hypertension (PPHN), with regard to neonatal outcome, oxygenation, and safety.

Methods: Randomized, placebo-controlled, double-masked, dose-response, clinical trial at 25 tertiary centers from April 1994 to June 1996. The primary endpoint was the PPHN Major Sequelae Index ([MSI], including the incidence of death, extracorporeal membrane oxygenation (ECMO), neurologic injury, or bronchopulmonary dysplasia [BPD]).

Rapid 1% increases of end-tidal desflurane concentration to greater than 5% transiently increase heart rate and blood pressure in humans.

Background: Large (0.5-1.0 MAC), rapid increases of desflurane to concentrations greater than 5% can transiently increase heart rate, mean arterial blood pressure (MAP), sympathetic nerve activity, and plasma epinephrine concentration.

Rapid increase in desflurane concentration is associated with greater transient cardiovascular stimulation than with rapid increase in isoflurane concentration in humans.

Background: Increases in desflurane and isoflurane concentrations can transiently increase arterial blood pressure or heart rate or both during induction of anesthesia. The current study tested the hypothesis that a rapid increase of desflurane concentration in humans increases sympathetic activity and hormonal variables and heart rate and arterial blood pressure more than does an equivalent increase in isoflurane concentration.

Methods: Twelve healthy male volunteers were assigned randomly to receive desflurane and on a separate occasion isoflurane.

Safety and potency of ANQ 9040 in male volunteers.

Background: ANQ 9040 is an experimental nondepolarizing neuromuscular relaxant. Initial investigations in animals had indicated a rapid onset of action comparable to that of succinylcholine. The purpose of this study was to assess the safety and potency of ANQ 9040 in humans.

Clinical characteristics of desflurane in surgical patients: minimum alveolar concentration.

Desflurane (formerly I-653) is a new inhalaticnal anesthetic with a promising pharmacokinetic profile that includes low solubility in blood and tissue, including fat. Since its lipid solubility is less than that of other volatile agents, it may have lower potency. Low solubility would be expected to increase the rate at which alveolar concentration approaches inspired concentration during induction as well as to increase the rate of elimination of desflurane from blood at emergence.

Biotransformation and hepato-renal function in volunteers after exposure to desflurane (I-653).

Ten healthy unpremedicated male volunteers were exposed to an average inspired concentration of 3.6% desflurane (I-653) in oxygen for 89 (SD 17) min. Standard haematological and biochemical tests were performed before (control) and immediately after exposure and at 4, 24, 72 and 192 h.

General versus epidural anesthesia for femoral-popliteal bypass surgery.

This study examines whether epidural anesthesia is more effective than general anesthesia using an inhalation agent in controlling cardiovascular responses during femoral-popliteal bypass surgery. Nineteen patients were randomized into two groups: general anesthesia (n = 10) and epidural anesthesia (n = 9). The patients who underwent general anesthesia received sodium pentothal and succinylcholine for induction of anesthesia and 60% N2O, 40% O2, and 1% to 1.

Kinetics and potency of desflurance (I-653) in volunteers.

The inhalation anesthetic, desflurance (I-653), is a methyl ethyl ether halogenated entirely with fluorine and differing from isoflurance only in the substitution of fluorine for chlorine on the alpha-ethyl carbon. Relative to presently used potent inhalation anesthetics, desflurane has low blood/gas (0.42) and oil/gas (18.

Is sufentanil removed by blood conservation devices?

To conserve blood during open heart surgery, cell savers and hemoconcentrators are used. Cell savers retrieve and filter shed blood from the operative field and then wash and separate reconcentrated erythrocytes from a supernatant by centrifugation. Hemoconcentrators are extracorporeal devices that extract an ultrafiltrate from the circulating perfusate during cardiopulmonary bypass.

Do oxygen consumption and carbon dioxide production affect cardiac output after cardiopulmonary bypass?

This study examines the oxygen consumption (VO2) and carbon dioxide production (VCO2) occurring before, during, and after cardiopulmonary bypass (CPB) and whether they correlate with changes in cardiac output. Twenty-three patients undergoing open heart surgery were studied. Group 1 (N = 11) received fentanyl citrate, 50 micrograms/kg, intravenously during the induction of anesthesia.

Energy measurements and requirements of critically ill patients.

The energy expenditure of the critically ill patient is influenced by many factors, thus making it difficult to predict. Measurement of energy expenditure in mechanically ventilated patients receiving elevated oxygen concentrations requires a good understanding of the measurement technique and its limitations, whether it be the gas exchange or Fick method. More investigation is needed to better understand the determinants of energy expenditure, as well as the total energy requirements of the critically ill patient.

Response to tubular airway resistance in normal subjects and postoperative patients.

Critically ill patients must often breathe spontaneously through an endotracheal tube that acts as a fixed inspiratory and expiratory tubular airway resistor. Although this practice is common, its effect on the pattern of breathing is not known. The mean breathing patterns of seven normal, healthy male subjects and eight male patients who had undergone upper abdominal surgery 2-4 days previously were studied breathing through a mouthpiece fitted in random order with a 5, 6, 7, 8, or 15 mm diameter (17 mm long) resistor.

Evaluation of a non-invasive method for the measurement of metabolic rate in humans.

Measurements of oxygen consumption (VO2) and carbon dioxide production (VCO2) can be used to calculate energy expenditure. Such data are useful in the nutritional management of a variety of pathological conditions. This study is an evaluation in vitro and in vivo of the mating of a canopy and a Beckman metabolic measurement cart 1 (MMC).

Effect of routine intensive care interactions on metabolic rate.

The alterations in metabolic (oxygen consumption [VO2] and carbon dioxide production [VCO2]) and hemodynamic (heart rate and blood pressure) parameters caused by various common intensive care activities were examined in a group of 23 mechanically-ventilated critically-ill patients. The observed variations in metabolic rate can be classified into four categories as follows: (a) the lowest energy expenditure, which was associated with sleeping in the majority (83 percent) of instances; (b) resting, which was defined as a state where the patient was lying motionless with eyes open and responding to surrounding events, where VO2 and VCO2 averaged 9.1 +/- 7.

Abdominal aortic cross-clamping. Metabolic and hemodynamic consequences.

We address the question of whether an oxygen debt develops during a period of abdominal aortic cross-clamping that may explain observed hemodynamic changes. Group 1 received morphine sulfate (1 mg/kg) during induction of anesthesia. Group 2 received same dose of morphine sulfate.

Morphine and postoperative rewarming in critically ill patients.

Morphine sulfate (MSO4) has been demonstrated to attenuate the stress response. MSO4 might be useful in minimizing the stress associated with the perioperative period, particularly that due to awakening from anesthesia and rewarming. Two groups of critically ill patients who developed hypothermia (35.

Artifacts in measurement of resting energy expenditure.

Measurements of gas exchange have been demonstrated to be clinically useful in the care of critically ill and malnourished patients. Using principles of indirect calorimetry, resting energy expenditure (REE) can be calculated from gas exchange data and used as the basis for designing a nutritional support regimen as well as for following the patient's metabolic state. This study demonstrates that a relatively minor procedure, such as percutaneous muscle biopsy, can induce temporary but major increases in gas exchange and lead to an overestimation of REE.