scholarly journals Effect of acute normobaric hypoxia on passively simulated illusions: A double-blind randomized study

2021 ◽  
Vol 65 ◽  
pp. 23-28
Author(s):  
SK Iyer ◽  
A Kumar ◽  
SS Mohapatra
Keyword(s):  
Randomized Study ◽  
Normobaric Hypoxia ◽  
Double Blind ◽  
Spatial Disorientation ◽  
Hypoxic Conditions ◽  
Hypoxia Group ◽  
Significant Difference ◽  
Military Aviation ◽  
Acceleration And Deceleration ◽  
Rotary Wing

Introduction: Number of accidents in the past four decades in rotary wing flying in high altitude areas in the Indian Air Force have been attributed to spatial disorientation (SD) or hypoxia or both. Although the two aviation stressors; hypoxia and SD, have been studied independently, literature is scant on the combined effects of the two notorious factors in military aviation. Material and Methods: In a double-blind randomized control design, 32 healthy volunteers divided into two groups (hypoxia group and normoxia group) of 16 subjects each, participated in the study. Subjects in the hypoxia group were exposed to normobaric hypoxia with pre-mixed gases in cylinders with nitrox gas (simulating altitude of 22,000 ft) and the normoxia group was exposed to normal air. Autokinesis time (AT) and vestibular adaptation time (VAT) during acceleration and deceleration, in both clockwise and counter-clockwise turns, were studied as surrogates for SD in both hypoxia group and normoxia group in Disorientation Simulator. Results: Mean AT showed a statistically significant decrease (t = −2.2, P = 0.039) in hypoxia group compared to normoxia group. Similarly, a statistically significant reduction (F = 5.989, P = 0.016) in mean VAT was observed in in hypoxia group compared to normoxia group. There was no significant difference in the VAT in clockwise and counter-clockwise yaw rotation in both the groups. Conclusion: A significant reduction in AT indicates that hypoxia may increase the onset of autokinesis early. The changes in VAT in hypoxic conditions bring out a possible effect of hypoxia on the adaptability of the vestibular system in the angular motion environment.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

Double-Blind Comparison of Maternal Analgesia and Neonatal Neurobehaviour following Intravenous Butorphanol and Meperidine

1979 ◽  
Vol 7 (3) ◽  
pp. 224-230 ◽  
Author(s):  
Robert Hodgkinson ◽  
Robert W Huff ◽  
Robert H Hayashi ◽  
Farkhanda J Husain
Keyword(s):  
Side Effects ◽  
Severe Pain ◽  
Randomized Study ◽  
Analgesic Efficacy ◽  
Foetal Heart Rate ◽  
Efficacy And Safety ◽  
Cervical Dilation ◽  
Double Blind ◽  
Significant Difference ◽  
Blind Comparison

Butorphanol (1 mg and 2 mg) and meperidine (40 mg and 80 mg), given intravenously, were evaluated for analgesic efficacy and safety in a double-blind randomized study employing 200 consenting pre-partum patients in moderate to severe pain during the late first stage of labour. Both drugs provided adequate relief of pain to the mothers. There was no significant difference in the rate of cervical dilation, the foetal heart rate, the Apgar score, pain relief or neonatal neurobehavioural scores between those receiving butorphanol and those receiving meperidine. Twenty-two mothers who received butorphanol and eleven who received meperidine nursed their infants with no adverse effects observed. Side-effects were generally infrequent in this study; however, more side-effects were reported by the patients and observed by the investigator in the meperidine-treated cases (13%) than in the cases treated with butorphanol (2%).

The Effects of Short-Term Immunotherapy Using Molecular Standardized Grass and Rye Allergens Compared with Symptomatic Drug Treatment on Rhinoconjunctivitis Symptoms, Skin Sensitivity, and Specific Nasal Reactivity

2005 ◽  
Vol 133 (4) ◽  
pp. 538-543 ◽  
Author(s):  
L. Klimek ◽  
T. Mewes ◽  
H. Wolf ◽  
I. Hansen ◽  
J. Schnitker ◽  
...  
Keyword(s):  
Drug Treatment ◽  
Grass Pollen ◽  
Randomized Study ◽  
Provocation Test ◽  
Treated Group ◽  
Short Term ◽  
Skin Sensitivity ◽  
Double Blind ◽  
Nasal Provocation ◽  
Significant Difference

BACKGROUND: The efficacy and safety of short-term immunotherapy with molecular standardized allergens (STI) has been demonstrated by double-blind placebo-controlled clinical trials. The aim of this study was to compare STI with symptomatic drug treatment. METHODS: Forty-eight patients with rhinoconjunctivitis to grass and/or rye pollen were treated either with STI (ALK7, n = 24) plus anti-allergic drugs or anti-allergic drugs, alone (n = 24) in a prospective, randomized study. Symptoms and use of drugs were reported in patient diaries and titrated nasal provocation and skin prick tests were performed at baseline, before, and after season. RESULTS: Median overall symptom ( P = 0.022, U test) and medication scores ( P = 0.003) were significantly lower in the STI group, as was the result for a simultaneous analysis of conjunctival, nasal, and bronchial symptom scores and medication ( P = 0.005). Sensitivity in the nasal provocation test decreased in the STI group but not in the drug-treated group. These differences became significant directly after STI ( P = 0.027) as well as after the grass pollen season ( P < 0.001). Skin sensitivity did not change in the STI group but increased in the drug-treated group after season, with a significant difference between the two groups for the erythema ( P < 0.001). CONCLUSIONS: STI reduces grass pollen-induced rhinoconjunctivitis symptoms and drug use, and specific nasal reactivity and skin sensitivity, more efficiently than a standard symptomatic treatment.

Intravenous Ondansetron for Attenuation of Post Spinal Anesthesia Hypotension

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ahmed Saeed Mohamed Ibrahim ◽  
Rania Mahrous Aly Hussien ◽  
Hazem Mohamed Sabry Abdel Aziz Ahmed
Keyword(s):  
Spinal Anesthesia ◽  
Local Anesthetic ◽  
Normal Saline ◽  
Demographic Data ◽  
Randomized Study ◽  
P Value ◽  
Anthropometric Measures ◽  
Double Blind ◽  
Induced Hypotension ◽  
Significant Difference

Abstract Background Spinal Anesthesia is a common type of anesthesia used during many surgical procedures. This regional technique can be accomplished by administering an intrathecal dose of hyperbaric local anesthetic solution. The local anesthetic within the subarachnoid space can block sensory, motor and sympathetic pathways. Objectives The Purpose of this study was to find out the effectiveness of prophylactic administration of intravenous ondansetron for attenuation of spinal anesthesia induced hypotension in non-obstetric spinal anesthesia surgeries. Patients and Methods Therefore, A prospective double-blind, placebo-controlled, randomized study was found to be the most suitable design in order to achieve the study objectives. A total of 90 patients males & females included in the study, aged 20-40 years, and were divided equally into two groups: Group A received 8 mg ondansetron diluted in volume of 10 cm normal saline 5 minutes prior to spinal anesthesia. Group B received a placebo of 10 cm normal saline 5 minutes prior to spinal anesthesia. Results There was no statistically significant difference found between the two studied groups regarding demographic data, anthropometric measures, ASA score and total time of surgery. There was statistically significant increase in the incidence of hypotension immediately after spinal and at 5 min in placebo group than ondansetron group with p-value = 0.026 and 0.014 respectively. Conclusion The present study demonstrated that, among patients who received spinal anesthesia with bupivacaine for elective for surgeries below umbilicus, prophylactic intravenous ondansetron 8mg iv 5 mins prior to spinal anesthesia reduced spinal anesthesia induced hypotension decreases in SBP, MAP, and heart rate. Ondansetron did not have a significant effect on DBP. Ondansetron did not have a significant effect on DBP. The incidence of nausea and vomiting was lower following the administration of ondansetron, and vasopressor use and dosages were reduced.

Timing of operation for ruptured supratentorial aneurysms: a prospective randomized study

1989 ◽  
Vol 70 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Juha Öhman ◽  
Olli Heiskanen
Keyword(s):  
Aneurysmal Subarachnoid Hemorrhage ◽  
Anterior Part ◽  
Controlled Trial ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Double Blind ◽  
Content Type ◽  
Acute Surgery ◽  
Significant Difference ◽  
Fine Print

✓ A total of 216 patients with a ruptured aneurysm of the anterior part of the circle of Willis were enrolled into this prospective randomized study of timing of the operation after aneurysmal subarachnoid hemorrhage (SAH). Only patients in clinical Grades I to III (according to the classification of Hunt and Hess) who were admitted and randomly assigned to a treatment group within 72 hours after the SAH were included in the trial. The patients were randomly assigned to one of three operation groups: acute surgery (AS: 0 to 3 days after the SAH; day of SAH = Day 0), intermediate surgery (IS: 4 to 7 days after the SAH), or late surgery (LS: 8 days to an indefinite time after the SAH). Three patients (4.3%) in the IS group and six patients (8.6%) in the LS group died before surgery was undertaken. At 3 months post-SAH, 65 patients (91.5%) from the AS group were classified as independent compared to 55 (78.6%) from the IS group and 56 (80.0%) from the LS group. The management mortality rate in the AS group was 5.6% compared to 12.9% in the LS group. Of the 216 patients enrolled in the timing study, 159 were randomly assigned to an independent double-blind placebo-controlled trial of nimodipine in Grade I to III patients. A total of 79 patients received nimodipine and 80 placebo. When the nimodipine group and the no-nimodipine group (the 80 placebo-treated patients plus the 52 patients who were not entered into the nimodipine trial) were analyzed separately, a significant difference was seen in the outcome of the no-nimodipine group (dependent AS vs. dependent IS, p = 0.01). Nimodipine treatment was associated with a significant reduction of delayed ischemic deterioration (all operation groups combined, nimodipine vs. no nimodipine p = 0.01; LS with nimodipine vs. LS with no nimodipine, p = 0.03).

scholarly journals Preoperative Fasting Abbreviation and its Effects on Postoperative Nausea and Vomiting Incidence in Gynecological Surgery Patients

2020 ◽  
Vol 42 (08) ◽  
pp. 468-475
Author(s):  
Gisele Vissoci Marquini ◽  
Francisco Edes da Silva Pinheiro ◽  
Alfredo Urbano da Costa Vieira ◽  
Rogério Melo da Costa Pinto ◽  
Maria Gabriela Baumgarten Kuster Uyeda ◽  
...  
Keyword(s):  
At Risk ◽  
Postoperative Nausea ◽  
Randomized Study ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Gynecological Surgery ◽  
Preoperative Fasting ◽  
Double Blind ◽  
Significant Difference

Abstract Objective To investigate the effects of preoperative fasting abbreviation with a carbohydrate and protein-enriched solution, on postoperative nausea and vomiting (PONV) incidence in gynecological surgery patients, a population naturally at risk for such unpleasant episodes. Methods The present prospective double-blind randomized study was performed at The Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP), approved by the Human Research Ethics Committee of UNIFESP and the board of HMMOLC, and included in the Brazil Platform and in the Brazilian Clinical Trial Registry. After signing the consent form, 80 women, who were submitted to gynecological surgery in the period from January to June 2016, were randomized into 2 groups: control group (n = 42) and juice group (n = 38). They received, respectively, 200 mL of inert solution or liquid enriched with carbohydrate and protein 4 hours presurgery. The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA). Results The incidence of nausea and vomiting was lower than in the literature, to this population, with 18.9% (14/74) for the control group and 10.8% (8/74) for the juice group, respectively, with no statistically significant difference between the groups. Conclusion The incidence of nausea and vomiting was lower than in the literature, but it cannot be said that this is due to the abbreviation of fasting. It can provide greater comfort, with the possibility of PONV prevention in patients at risk for these episodes.

scholarly journals Polymorphism of μ-Opioid Receptor Gene (OPRM1:c.118A>G) Might Not Protect against or Enhance Morphine-Induced Nausea or Vomiting

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Li-Kuei Chen ◽  
Shiou-Sheng Chen ◽  
Chi-Hsiang Huang ◽  
Hong-Jyh Yang ◽  
Chen-Jung Lin ◽  
...  
Keyword(s):  
Side Effects ◽  
Opioid Receptor ◽  
Receptor Gene ◽  
Randomized Study ◽  
Patient Control Analgesia ◽  
Morphine Consumption ◽  
Nucleotide Position ◽  
Double Blind ◽  
Significant Difference ◽  
Equilibrium Test

A cohort, double blind, and randomized study was conducted to investigate the effect of a single nucleotide polymorphism of the μ-opioid receptor at nucleotide position 118 (OPRM1:c.118A>G) on the association with the most common side effects (nausea or vomiting) induced by intravenous patient control analgesia (IVPCA) with morphine, including incidence and severity analysis. A total of 129 Taiwanese women undergoing gynecology surgery received IVPCA with pure morphine for postoperative pain relief. Blood samples were collected and sequenced with high resolution melting analysis to detect three different genotypes of OPRM1 (AA, AG, and GG). All candidates 24 h postoperatively will be interviewed to record the clinical phenotype with subjective complaints and objective observations. The genotyping after laboratory analysis showed that 56 women (43.4%) were AA, 57 (44.2%) were AG, and 16 (12.4%) were GG. The distribution of genotype did not violate Hardy-Weinberg equilibrium test. There was no significant difference neither between the severity and incidence of IVPCA morphine-induced side effects and genotype nor between the association between morphine consumption versus genotype. However, there was significant difference of the relation between morphine consumption and the severity and incidence of IVPCA morphine-induced nausea and vomiting. The genetic analysis for the severity and incidence of IVPCA morphine-induced nausea or vomiting showed no association between phenotype and genotype. It might imply that OPRM1:c.118A>G does not protect against IVPCA morphine-induced nausea or vomiting.

scholarly journals The Potentially Positive Role of PRPs in Preventing Femoral Tunnel Widening in ACL Reconstruction Surgery Using Hamstrings: A Clinical Study in 51 Patients

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Konstantinos A. Starantzis ◽  
Dimitrios Mastrokalos ◽  
Dimitrios Koulalis ◽  
Olympia Papakonstantinou ◽  
Panayiotis N. Soucacos ◽  
...  
Keyword(s):  
Acl Reconstruction ◽  
Femoral Tunnel ◽  
Platelet Rich Plasma ◽  
Cruciate Ligament ◽  
Randomized Study ◽  
Tunnel Widening ◽  
Double Blind ◽  
Reconstruction Surgery ◽  
Significant Difference

Purpose. In this study, the early and midterm clinical and radiological results of the anterior cruciate ligament (ACL) reconstruction surgery with or without the use of platelet rich plasma (PRP) focusing on the tunnel-widening phenomenon are evaluated.Methods. This is a double blind, prospective randomized study. 51 patients have completed the assigned protocol. Recruited individuals were divided into two groups: a group with and a group without the use of PRPs. Patients were assessed on the basis of MRI scans, which were performed early postoperatively and repeated at least one-year postoperatively. The diameter was measured at the entrance, at the bottom, and at the mid distance of the femoral tunnel.Results. Our study confirmed the existence of tunnel widening as a phenomenon. The morphology of the dilated tunnels was conical in both groups. There was a statistical significant difference in the mid distance of the tunnels between the two groups. This finding may support the role of a biologic response secondary to mechanical triggers.Conclusions. The use of RPRs in ACL reconstruction surgery remains a safe option that could potentially eliminate the biologic triggers of tunnel enlargement. The role of mechanical factors, however, remains important.

scholarly journals Randomized study of 13-cis retinoic acid v placebo in the myelodysplastic disorders

Blood ◽  
1988 ◽  
Vol 71 (3) ◽  
pp. 703-708 ◽  
Author(s):  
HP Koeffler ◽  
D Heitjan ◽  
R Mertelsmann ◽  
JE Kolitz ◽  
P Schulman ◽  
...  
Keyword(s):  
Retinoic Acid ◽  
Therapeutic Effect ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Skin Toxicity ◽  
Response To Treatment ◽  
Double Blind ◽  
Minor Response ◽  
Bone Marrow Biopsies ◽  
Significant Difference

Abstract A double-blind, placebo-controlled randomized trial of 13-cis retinoic acid was performed to determine if the drug has a therapeutic effect in patients with myelodysplastic syndromes (MDS). Sixty-eight evaluable patients with MDS were randomized to receive a single, daily oral dose of either 13-cis retinoic acid (13-CRA, 100 mg/m2) or matching placebo. Treatment was continued, when possible, for a period of 6 months. Determination of response to treatment was based on clinical course, repeat bone marrow biopsies, and aspirates and blood counts (CBC) with WBC differential, platelet, and reticulocyte numbers at specified intervals. No significant difference was noted between the two treatment groups in response to test drug (P = .66). One patient (3%) in the 13-CRA group and two patients (6%) in the placebo group had a minor response. Approximately 30% of patients in both groups had progression of their disease, and progression-free survival was nearly identical. Greater than 90% of the patients receiving 13-CRA developed mild or moderate skin toxicity that was reversible with decreasing or discontinuing the drug. Our study did not find that 13-CRA exerts a beneficial therapeutic effect in patients with MDS.

Loratadine (SCH29851) 40 mg Once Daily versus Terfenadine 60 mg Twice Daily in the Treatment of Seasonal Allergic Rhinitis

1987 ◽  
Vol 15 (2) ◽  
pp. 63-70 ◽  
Author(s):  
G. Bruttmann ◽  
P. Pedrali
Keyword(s):  
Allergic Rhinitis ◽  
Placebo Group ◽  
Randomized Study ◽  
Placebo Patient ◽  
Double Blind ◽  
Once Daily ◽  
Treatment Groups ◽  
Nasal Symptoms ◽  
Active Medication ◽  
Significant Difference

Seventy patients received loratadine 40 mg once daily, terfenadine 60 mg twice daily, or placebo in a 14-day, double-blind, randomized study. Four nasal and four non-nasal symptoms associated with allergic rhinitis were evaluated. At the endpoint (the last evaluable visit), the mean total scores of combined nasal and non-nasal symptoms decreased (improved) from the baseline by 51.8% and 55.7% with loratadine and terfenadine, respectively, but increased (worsened) by 6.1% with placebo. There was a significant difference between both the loratadine and terfenadine treatment groups and the placebo group ( P=0.001) but not between the active medication groups ( P=0.608). Overall therapeutic response was good or excellent in 14 of the 23 patients given loratadine, in 18 of the 24 given terfenadine and in none of the 23 given placebo. The difference between each active medication group and the placebo group was significant ( P≤0.01) but there was no significant difference between the two active treatment groups ( P>0.35). No loratadine patient had any adverse side-effects. Sedating effects occurred in one terfenadine patient, headache in one placebo patient and two terfenadine patients (one terfenadine patient with severe headache discontinued treatment), and dyspepsia in two placebo patients. No anti-cholinergic effects occurred in this study. Loratadine 40 mg once daily was effective and safe in the relief of symptoms of allergic rhinitis.

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