Propofol compared with the morphine, atropine, and suxamethonium regimen as induction agents for neonatal endotracheal intubation: a randomized, controlled trial. A randomized-controlled trial of prophylactic hydrocortisone supplementation for the prevention of hypotension in extremely low birth weight infants. [Prophylaxis of intraoperative nausea and vomiting with sub-hypnotic dose of propofol during intradural anesthesia in cesarean section]. Sedation with propofol for interventional endoscopy by trained nurses in high-risk octogenarians: a prospective, randomized, controlled study. Target-controlled versus manually-controlled infusion of propofol for direct laryngoscopy and bronchoscopy. A double-blind randomized controlled trial on the use of prophylactic antibiotics in patients undergoing elective caesarean section. [Efficacy of propofol and propofol plus dexamethasone in controlling postoperative nausea and vomiting of gynecologic laparoscopy.]. Subhypnotic doses of propofol relieve pruritus induced by epidural and intrathecal morphine. The antiemetic efficacy and safety of prophylactic metoclopramide for elective cesarean delivery during spinal anesthesia.
The purpose of this work was to compare the efficacy of propofol, a hypnotic agent, to the regimen of morphine, atropine, and suxamethonium as an induction agent for nonemergency neonatal endotracheal intubation. We hypothesized that propofol aids intubation by allowing the continuation of spontaneous breathing.
                We conducted a randomized, open-label, controlled trial of infants who required nonemergency endotracheal intubation. Primary outcome was successful intubation confirmed by chest auscultation and clinical examination of the infant.
                Infants randomly assigned to propofol (n = 33) and the morphine, atropine, and suxamethonium regimen (n = 30) were comparable in median gestational age (27 vs 28 weeks), birth weight (1020 vs 1095 g), weight at intubation (1068 vs 1275 g), and age at intubation (4 vs 3 days). Sleep or muscle relaxation were achieved within 60 seconds in both groups, but time to achieve successful intubation was more than twice as fast with propofol (120 vs 260 seconds). Blood pressure and heart rates were not different, but intraprocedural oxygen saturations were significantly lower in infants on the morphine, atropine, and suxamethonium regimen (trough arterial oxygen saturation: 60% vs 80%). Nasal/oral trauma was less common, and recovery time was shorter (780 vs 1425 seconds) in the propofol group. No significant adverse effects were seen in either group.
                Propofol is more effective than the morphine, atropine, and suxamethonium regimen as an induction agent to facilitate neonatal nasal endotracheal intubation. Importantly, hypoxemia was less severe, probably because of the maintenance of spontaneous breathing. A controlled environment may have promoted the ease of intubation, resulting in less trauma. The shorter duration of action would be advantageous in a compromised infant. Extremely low birth weight (ELBW) infants are at risk for hypotension. Abnormal adrenal function may play a role in the pathogenesis of hypotension, and therefore, the administration of hydrocortisone (HC) may be an effective treatment for hypotension in some infants. However, the efficacy of prophylactic HC to prevent the use of vasopressors for a defined hypotensive state has not been studied. We conducted a randomized-controlled trial to determine the potential role on adrenal insufficiency in early neonatal hypotension and to determine the effectiveness of prophylactic HC in reducing treatment of hypotension in ELBW infants.
                Infants were assigned to receive either HC or placebo within the first 3 hours of life. Therapy was continued for 5 days. The presence of hypotension was based on an operational definition and treatment with vasopressors (VP) was standardized based on an a priori protocol.
                A total of 34 patients were enrolled. Baseline characteristics were similar between groups. Of the HC group 25% received VP at 24 hours of age compared to 44% of the placebo group. On day of life 2, only 7% of the HC group received VP compared to 39% of the placebo group (p<0.05).
                Prophylactic treatment with HC reduces the incidence of hypotension, defined by treatment with VP, among ELBW infants during the first 2 days of life. However, the mounting evidence that prophylactic administration of glucocorticoids in the first days of life is harmful to ELBW infants makes HC prophylaxis unwise until the efficacy of treatment relative to safety can be clearly established. To determine the preventive and therapeutic effect of 10 mg of propofol administered after delivery on the incidence of intraoperative nausea and vomiting (IONV) during intradural anesthesia for cesarean delivery.
                Controlled, randomized double blind study of 60 women (ASA I-II) receiving intradural anesthesia for elective or deferred emergency cesarean delivery. The propofol group received 10 mg i.v. immediately after fetal extraction. The control group received an equal volume of Intralipid. The presence of IONV after administration of the prophylactic bolus was treated with a second bolus, and if nausea had not subsided completely after two minutes, treatment was topped up with dehydro-benzoperidol.
                The control group included 31 women and the propofol group 29, of whom 3 were excluded. Control variables were similar in the two groups. There were no significant differences in the incidence and severity of IONV between the two groups (22.5 versus 23%). The top-up antiemetic drug was used in the same number of patients in each group.
                Although 10 mg propofol has been described as an effective direct antiemetic, episodes of IONV were neither prevented nor reversed by its use during intradural anesthesia for cesarean delivery. Sedation with the short-acting anesthetic agent propofol has shown several advantages, particularly in interventional endoscopy. So far, however, there are no valid data on the safety of nurse-administered propofol sedation (NAPS) during interventional endoscopy in elderly high-risk patients.
                A total of 150 patients aged > 80 years with high comorbidity were randomized to receive midazolam plus meperidine (n = 75) or propofol alone (n = 76) for sedation during endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), or double-balloon endoscopy (DBE). Sedation was supervised by a trained nurse and a trained physician both of whom were not involved in the endoscopic procedure. Vital signs were continuously monitored as well as patient cooperation and tolerance. Mortality and morbidity at 30 days was analyzed.
                The overall cardiopulmonary complication rate was 16 % in the midazolam group and 23.7 % in the propofol group ( P > 0.05). The mean decline in oxygen saturation (initial vs. lowest O (2) saturation) and the mean decline of blood pressure (initial vs. lowest blood pressure) were significantly greater with propofol (7 % +/- 3 % vs. 4 % +/- 2 % [ P < 0.05] and 10 % +/- 2 % vs. 8 % +/- 2 %, respectively [ P < 0.05]). No procedure had to be interrupted due to serious adverse events. Patient cooperation was statistically significantly better in the propofol group (7 +/- 2 vs. 5 +/- 2 points). Patients sedated with propofol showed a significantly lower oxygen saturation rate during recovery time (8 % vs. 28 %; P < or = 0.01).
                NAPS during interventional endoscopy is as safe as midazolam/pethidine sedation even in high-risk patients aged > 80 years. Few studies have compared the clinical profile of target-controlled infusions of propofol with that of manually-controlled infusions. Fifty-four ASA physical status I or II patients scheduled for an elective otorhinolaryngology endoscopy performed under general anesthesia with spontaneous ventilation were enrolled in this prospective randomized study to compare the clinical outcome of such administrations. Before induction, all patients received a single alfentanil bolus dose (10 microg/kg). Propofol administration was adapted to maintain absence of movement, hemodynamic stability, and efficient spontaneous ventilation. When compared with the Manually-Controlled Infusion group, in the Target-Controlled Infusion group there were fewer movements at insertion of the laryngoscope (14.8% vs. 44.4%), improved hemodynamic stability (largest variations of mean arterial blood pressure <10% of control values, versus 20%), fewer episodes of apnea, and less respiratory acidosis after endoscopy (pH = 7.37 +/- 0.05 and PaCO(2) = 50 +/- 7 mm Hg versus pH = 7.28 +/- 0.06 and PaCO(2) = 58 +/- 9 mm Hg); the recovery was also shorter (time to opening eyes or verbal response, 4.6 +/- 2.0 min and 6.8 +/- 2.5 min versus 10.8 +/- 7.3 min and 15.7 +/- 7.1 min). Propofol consumption was comparable in the two groups. Targeting the effect-site concentration improved the time course of the propofol drug effect during direct laryngoscopy performed during spontaneous ventilation when compared with manual infusion.
                This study compares the clinical profile of propofol anesthesia for direct laryngoscopy with spontaneous ventilation when the drug is administered either as a manually controlled infusion or by targeting the effect-site concentration through a target-controlled infusion (TCI) device. TCI improves the time course of propofol effects. In a double-blind randomized controlled study 232 patients undergoing elective lower segment caesarean section were randomly allocated to receive a pre-operative prophylactic dose of a combination of crystalline penicillin and chloramphenicol or a placebo. The two groups were comparable in terms of patient characteristics and operation variables. The group receiving antibiotics had significantly fewer febrile and infectious morbid events and thus spent fewer days in hospital than the group receiving the placebo. Gynecological laparoscopy is a procedure associated to a high incidence of postoperative nausea and vomiting (PONV). This study aimed at comparing the efficacy of propofol or propofol plus dexamethasone in preventing PONV in patients submitted to gynecological laparoscopy.
                Forty female patients, physical status ASA I and II, aged 18 to 46 years, with no previous gastric complaint, undergoing diagnostic or surgical laparoscopy were randomly distri- buted in 2 groups: Group 1 - patients were given 2 ml IV saline solution, while Group 2 was given intravenous dexamethasone (8 mg), before anesthetic induction. All patients were premedicated with oral midazolam (7.5 mg) and induced with sufentanil (0.5 microg.kg-1) and propofol targed controlled infusion (BIS 60), with N2O/O2 (F I O2=0.4) for maintenance. Neuromuscular block was obtained with atracurium (0.5 mg.kg-1). Postoperative analgesia consisted of ketoprofen (100 mg) and butyl-eschopolamine plus dipirone. Patients were evaluated in the PACU and in the ward after 1, 2, 3 and 12 hours after PACU discharge.
                Both groups were identical regarding demographics data as well as surgery and anesthesia duration. One Group 1 patient referred nausea in postanesthetic care unit and in the ward, and 3 patients referred vomiting in the ward. In Group 2, no patient referred nausea and vomiting, but the difference was not statistically significant.
                Propofol or propofol plus dexamethasone were efficient in preventing PONV in patients submitted to gynecological laparoscopy. We investigated the efficacy of subhypnotic doses of propofol for spinal morphine-induced pruritus in a prospective, randomized, double-blind, placebo-controlled study. Fifty patients, ASA physical status 1-3, with spinal morphine-induced pruritus were allocated to receive either 1 ml propofol (10 mg) or 1 ml placebo (Intralipid) intravenously after gynecologic, orthopedic, thoracic, or gastrointestinal surgery. In the absence of a positive response, a second drug treatment was given 5 min later. The persistence of pruritus 5 min after the second treatment dose was considered a treatment failure. All failures then received, in an open fashion, a supplementary dose of propofol (10 mg) and were reevaluated 5 min later. Both groups were well matched. The success rate was significantly greater in the propofol group (84%) than in the placebo (16%) group (P less than 0.05). Ninety percent of the treatment failures in the placebo group were successfully treated by a supplementary dose of 10 mg propofol. Eight percent of the patients (4% in each group) were resistant to all treatments, including naloxone 0.08 mg intravenously. Three patients had a slight increase in sedation in the propofol group versus none in control (not significant). The beneficial effect of treatment was longer than 60 min in 85% of patients in the propofol group and in 100% of the controls (not significant). These results suggest that propofol in a subhypnotic dose is an efficient drug treatment for spinal morphine-induced pruritus. At the dose administered (10 mg), side effects were rare and minor. The efficacy and safety of intravenous metoclopramide administered prophylactically before elective cesarean delivery under spinal anesthesia was studied.
                In a double-blind, randomized fashion, 42 ASA Physical Status I-II parturients at term were assigned to receive either 10-mg intravenous metoclopramide or an equal volume of normal saline before induction of spinal anesthesia. The occurrence of nausea and/or vomiting recorded throughout the perioperative period until the patient was admitted to the recovery room. Neonatal acid-base status and neurobehavioral exams were obtained.
                Patients in the group receiving metoclopramide had a significantly lower incidence of nausea and vomiting both before and after delivery than the control group (14% versus 81% overall). All neonatal acid-base values were within normal limits and there were no significant differences in neurobehavioral exam results between the two groups.
                Metoclopramide administered before induction of spinal anesthesia for cesarean delivery appears to significantly reduce both pre- and postdelivery emetic symptoms without apparent adverse effects on mother or neonate.
No practice recommendation can be made based on the available evidence regarding the use of propofol in neonates. Further research is needed on the pharmacokinetics of propofol in neonates and once a relatively safe dose is identified, randomised controlled trials assessing the safety and efficacy of propofol are needed.