Efficacy of Bispectral Monitoring As An Adjunct to Propofol Deep Sedation for ERCP: A Randomized Controlled Trial

2009 ◽  
Vol 69 (5) ◽  
pp. AB208-AB209
Author(s):  
Irene Hainaki ◽  
Maria Manolaraki ◽  
Georgios Tribonias ◽  
Konstantinos Konstantinidis ◽  
Emmanouil Vardas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Deep Sedation ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Manual versus target-controlled infusion of balanced propofol during diagnostic colonoscopy: A prospective randomized controlled trial

2016 ◽  
Vol 144 (9-10) ◽  
pp. 514-520 ◽  
Author(s):  
Vera Vucicevic ◽  
Branko Milakovic ◽  
Milorad Tesic ◽  
Jelena Djordjevic ◽  
Srdjan Djuranovic
Keyword(s):  
Randomized Controlled Trial ◽  
Deep Sedation ◽  
Controlled Trial ◽  
Diagnostic Colonoscopy ◽  
Randomized Controlled ◽  
Target Controlled Infusion ◽  
Prospective Randomized Controlled Trial ◽  
American Society ◽  
Balanced Propofol Sedation ◽  
Outpatient Settings

Introduction. There is an increasing interest in balanced propofol sedation (BPS) for colonoscopy in outpatient settings. Propofol is a potent anesthetic agent for this purpose and has a narrow therapeutic range, which increases a risk of cardiovascular and respiratory complications in case of improper administration. Objective. The aim of this study was to compare patients? safety and comfort of endoscopists in two methods of BPS targeting deep sedation - propofol target-controlled infusion (TCI) and manual intravenous titration technique (MT) - during colonoscopy. Methods. This prospective randomized controlled trial included 90 patients (class I or II of the American Society of Anesthesiologists) deeply sedated with propofol, coadministered with small doses of midazolam and fentanyl. Propofol was given by MT technique (45 patients) or by TCI (45 patients). The following adverse effects were recorded: hypotension, hypertension, bradycardia, tachycardia, hypoxemia, bradypnea, apnea, hiccupping, and coughing, as well as endoscopist?s comfort during colonoscopy by means of a questionnaire. Results. The MT group compared to the TCI group had a lower mean arterial pressure in the 10th minute after the beginning (p = 0.017), and at the end of colonoscopy (p = 0.006), higher oxygen saturation in the fifth minute (p = 0.033), and in the 15th minute (p = 0.008) after the beginning of colonoscopy, and lower heart rate at the beginning of the procedure (p = 0.001). There were no statistically significant differences in adverse events. Endoscopist?s comfort during colonoscopy was high 95.6% in the TCI group vs. 88.9% in the MT group (p = 0.069). Conclusion. MT is clinically as stable as TCI of propofol for deep sedation during colonoscopy, and endoscopists experienced the same comfort during colonoscopy in both groups. Thus, both combinations are suitable for deep sedation during diagnostic colonoscopy.

Efficacy of bispectral index monitoring as an adjunct to propofol deep sedation for ERCP: a randomized controlled trial

Endoscopy ◽  
2009 ◽  
Vol 41 (12) ◽  
pp. 1046-1051 ◽  
Author(s):  
G. Paspatis ◽  
I. Chainaki ◽  
M. Manolaraki ◽  
E. Vardas ◽  
A. Theodoropoulou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Bispectral Index ◽  
Deep Sedation ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Bispectral Index Monitoring

Capnography Prevents Hypoxia during Sedation for Dental Treatment: A Randomized Controlled Trial

2016 ◽  
Vol 2 (2) ◽  
pp. 158-167
Author(s):  
K. Takaya ◽  
H. Higuchi ◽  
M. Ishii-Maruhama ◽  
A. Yabuki-Kawase ◽  
Y. Honda ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intellectual Disabilities ◽  
Dental Treatment ◽  
Deep Sedation ◽  
Controlled Trial ◽  
Independent Observer ◽  
Randomized Controlled ◽  
Group I ◽  
Alveolar Hypoventilation ◽  
Capnographic Monitoring

Intravenous sedation is useful for dental treatment in patients with intellectual disabilities. However, it is often necessary to manage such patients with deep sedation because their cooperation cannot be obtained. During deep sedation, undetected hypoventilation can lead to severe complications, such as hypoxia. Recently, capnographic monitoring has been advocated as a useful technique for preventing hypoxia during sedation. This randomized control trial evaluated whether the use of capnography reduces the incidence of hypoxia during the deep sedation of patients for dental treatment. This study involved patients with intellectual disabilities who underwent dental treatment under sedation. The subjects were randomized to the intervention group (I-group) or control group (C-group). All of the patients underwent routine monitoring, as well as bispectral index (BIS) and capnographic monitoring; however, only an independent observer had access to the patients’ capnographic data during the dental procedures. Sedation was maintained at a BIS of 50 to 70 by administration of propofol. In the I-group, the independent observer signaled to the dental anesthesiologist if the capnogram indicated that the patient had been suffering from alveolar hypoventilation or apnea for >15 s. In the C-group, the observer signaled to the dental anesthesiologist if the capnogram indicated that the patient had been suffering from alveolar hypoventilation or apnea for >60 s. In both groups, the dental anesthesiologists responded to the signals using appropriate airway management strategies. The primary endpoint of this study was the incidence of hypoxia during dental treatment, which was defined as oxygen saturation of <95%. Hypoxemic episodes occurred in 13.4% and 34.8% of cases in the I-group and C-group, respectively. The incidence of hypoxia was significantly lower in the I-group. These results suggest that capnographic monitoring during deep sedation for dental treatment prevents hypoxemic episodes by allowing the early detection of hypoventilation. Knowledge Transfer Statement: This is the first randomized controlled trial to examine whether the use of capnography reduces the incidence of hypoxia during deep sedation for dental treatment. The findings of this study can be used by clinicians to aid decision-making regarding dental sedation standards at individual clinics. Moreover, they can be used as high-level evidence during the production or updating of clinical guidelines for dental sedation by leading associations.

W1434: Deep Sedation Compared With Moderate Sedation in Polyp Detection During Colonoscopy: A Randomized Controlled Trial

2010 ◽  
Vol 71 (5) ◽  
pp. AB327
Author(s):  
Georgios Tribonias ◽  
Konstantinos Konstantinidis ◽  
Angeliki Theodoropoulou ◽  
Emmanouil Vardas ◽  
Konstantinos Karmiris ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Deep Sedation ◽  
Controlled Trial ◽  
Polyp Detection ◽  
Moderate Sedation ◽  
Randomized Controlled

Deep sedation compared with moderate sedation in polyp detection during colonoscopy: a randomized controlled trial

2011 ◽  
Vol 13 (6) ◽  
pp. e137-e144 ◽  
Author(s):  
G. A. Paspatis ◽  
G. Tribonias ◽  
M. M. Manolaraki ◽  
K. Konstantinidis ◽  
I. Chainaki ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Deep Sedation ◽  
Controlled Trial ◽  
Polyp Detection ◽  
Moderate Sedation ◽  
Randomized Controlled

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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