scholarly journals A randomised study of comfort during bronchoscopy comparing conscious sedation and anaesthetist controlled general anaesthesia, including the utility of Bispectral Index (BIS) monitoring

2021 ◽  
pp. 00895-2020
Author(s):  
Thomas R. Skinner ◽  
Joseph Churton ◽  
Timothy P. Edwards ◽  
Farzad Bashirzadeh ◽  
Christopher Zappala ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
General Anaesthesia ◽  
Bispectral Index ◽  
Conscious Sedation ◽  
Randomised Trial ◽  
Patient Comfort ◽  
Randomised Study ◽  
Repeat Procedure ◽  
Significant Difference ◽  
The Difference

BackgroundThe difference in patient comfort with conscious sedation (CS) versus general anaesthesia (GA) for bronchoscopy has not been adequately assessed in a randomised trial. This study aimed to assess if patient comfort during bronchoscopy with CS is non-inferior to GA.Methods96 subjects were randomized to receive CS or GA for bronchoscopy. The primary outcome was subject comfort. Secondary outcomes included: Willingness to undergo a repeat procedure if necessary andlevel of sedation assessed clinically and by Bispectral Index (BIS) monitoring.ResultsThere was no significant difference between subject comfort scores (difference −0.01 (95% CI −0.63, 0.61 on a 10 point scale,, p=0.97) or willingness to undergo a repeat procedure (97.7% versus 91.8%, (95% CI −4.8%, 15.5%); p=0.37). Deeper levels of sedation in the GA cohort was confirmed with both clinical and BIS. There was no significant difference in diagnostic accuracy (CS: 93.9% (95% CI 80.4%, 98.3%) versus GA: 86.5% (95% CI 72.0%, 94.1%); p=0.43). There were more complications (29.6% (95% CI 18.2%, 44.2%) versus 6.1% (95% CI 2.1%, 16.5%); p<0.01) in the GA group. There was no relationship between high BIS scores and subject discomfort. BIS levels of less than 40 during a procedure was associated with increased complications.ConclusionCS is not inferior to GA in providing patient comfort during bronchoscopy despite lighter sedation and is associated with fewer complications and comparable diagnostic accuracy. BIS monitoring may have a role in preventing complications associated with deeper sedation.

Continuous, transcutaneous carbon-dioxide monitoring to avoid hypercapnia in complex catheter ablations under conscious sedation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Weinmann ◽  
A Lenz ◽  
R Heudorfer ◽  
D Aktolga ◽  
M Rattka ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Conscious Sedation ◽  
Venous Blood ◽  
Patient Comfort ◽  
Carbon Dioxide Partial Pressure ◽  
Close Monitoring ◽  
Blood Gas ◽  
Transcutaneous Carbon Dioxide ◽  
The Difference ◽  
Venous Blood Gas

Abstract Background Ablation of complex cardiac arrhythmias requires an immobilized patient. For a successful and safe intervention and for patient comfort, this can be achieved by conscious sedation. Administered sedatives and analgesics have respiratory depressant side effects and require close monitoring. Purpose We investigated the feasibility and accuracy of an additional, continuous transcutaneous carbon-dioxide partial pressure (tpCO2) measurement during conscious sedation in complex electrophysiological catheter ablation procedures. Methods We evaluated the accuracy and additional value of tpCO2 detection by application of a Severinghaus electrode in comparison to arterial and venous blood gas analyses. Results We included 110 patients in this prospective observational study. Arterial pCO2 (paCO2) and tpCO2 showed good correlation throughout the procedures (r=0.60–0.87, p&lt;0.005). Venous pCO2 (pvCO2) were also well correlated to transcutaneous values (r=0.65–0.85, p&lt;0.0001). Analyses of the difference of pvCO2 and tpCO2 measurements showed a tolerance within &lt;10mmHg in up to 96–98% of patients. Hypercapnia (pCO2&lt;70mmHg) was detected more likely and earlier by continuous tpCO2 monitoring compared to half-hourly pvCO2 measurements. Conclusion Continuous tpCO2 monitoring is feasible and precise with good correlation to arterial and venous blood gas carbon-dioxide analysis during complex catheter ablations under conscious sedation and may contribute to additional safety. Funding Acknowledgement Type of funding source: None

F2695: A New Therapeutic Potential for Major Depression. A Phase II Double-blind Randomised Trial Results

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
L. Mansuy
Keyword(s):  
Major Depression ◽  
Depressive Disorders ◽  
Therapeutic Potential ◽  
Randomised Trial ◽  
Major Depressive ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Significant Difference ◽  
Major Depressive Disorders ◽  
The Difference

F2695 is a novel antidepressant exerts simultaneous noradrenergic and serotoninergic neurotransmitter effects.F2695 SR was administered in patients with Major Depression in a randomized, multinational, double-blind, placebo-controlled 10-week study, assessing the efficacy and safety of F2695 SR progressive titration safety adapted doses from 75 mg to 100 mg od, in out-patients with Major Depressive Disorders. The 563 randomized patients fulfilled the diagnostic criteria for Major Depressive Disorders and presented moderate or severe Major Depressive Disorders. Efficacy analysis found a significant difference between F2695 and placebo in favour of the active treatment in term of a significantly greater improvement in MADRS total score with F2695 compared with placebo (p< 0.0001). In addition, significantly more patients achieved MADRS response (a decrease in total score equal or superior to 50%) and MADRS remission (defined as a total score inferiorior to10) in the F2695 group than in the placebo group such an effect being usually not seen on this measure in the relatively short time span of a ten-week study. At the doses tested, F2695 was effective from early in the treatment (week 2) and the difference in efficacy compared with placebo increased steadily throughout the study.The severity to entry in this study was relatively high and the mean MADRS entry score was 31, about 40% of patients were in the severe category of depression.This study: provided evidence of the efficacy of F2695 in major depression population. Therapeutic effect was sustained in term of effect-size, responders and remissions rate, in front of placebo.

Safety and efficacy of fentanyl combined with midazolam in bronchoscopy under bispectral index-guided conscious sedation

2020 ◽  
Author(s):  
qian he ◽  
sujuan zhang ◽  
jun zhou ◽  
xiong xu ◽  
qianqian xu ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Local Anesthesia ◽  
Bispectral Index ◽  
Conscious Sedation ◽  
Vital Signs ◽  
Transbronchial Biopsy ◽  
Endobronchial Ultrasound ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
Vas Scores

Abstract Background: Sedation combined with local anesthesia during bronchoscopy is widely accepted in America and Europe, and receiving great attention in China. This study aimed to investigate the safety and efficacy of fentanyl combined with midazolam for bispectral index (BIS) titrated conscious sedation during bronchoscopy in the Chinese population. Methods: Data from 436 patients who underwent bronchoscopy under local anesthesia (LA group) or BIS-guided conscious sedation combined with local anesthesia (FM group) were retrospectively analyzed. The analysis included vital signs, adverse events recorded during the procedure, and questionnaire information, such as patient tolerance and satisfaction, operator satisfaction, and the cough score noted after the procedure. Results: A total of 225 patients in the LA group, and 211 in the FM group were enrolled in the study. The blood pressure and oxygen saturation were significantly higher in the LA group than in the FM group during bronchoscopy (P<0.001). The heart rate was significantly faster in the LA group at T3max, T3min and T4 than in the FM group. The incidence of hypoxia and bradycardia was higher in the FM group than in the LA group, whereas incidence of hypertension and tachycardia was lower. Patient satisfaction and tolerance of the procedure were significantly better in the FM group. visual analog scale (VAS) scores for cough and operator satisfaction were better in the FM group than in the LA group. Sub-group analysis (inspection, biopsy and transbronchial biopsy guided by radial endobronchial ultrasound (rEBUS-TBB)) indicated that the vital signs, adverse event(hypoxia) and patient satisfaction of the two groups were similar to the previous results. However, the VAS scores for operators’ satisfaction was no significant difference between the two groups in patients undergoing inspection. Conclusions: The conscious sedation regimen of fentanyl combined with midazolam monitored by BIS during bronchoscopy is safe and effective. Although the incidence of hypoxia and bradycardia was higher, the patient’s tolerance and physician’s satisfaction were significantly improved, especially during lengthy procedures, such as intrabronchial biopsy and transbronchial biopsy guided by radial endobronchial ultrasound. Trial registration: The study was approved by the ethics committee of Changzhou first people's Hospital (2019-020).

scholarly journals Comparative analysis of immediate and delayed insertion of flexible cystoscope after application of topical anaesthetic lubricant on patient comfort

2019 ◽  
Vol 6 (9) ◽  
pp. 3096
Author(s):  
Zubair Bhat ◽  
Mudassir Wani
Keyword(s):  
Patient Comfort ◽  
Small Subset ◽  
Flexible Cystoscopy ◽  
Pain Scores ◽  
Flexible Cystoscope ◽  
Significant Difference ◽  
Delayed Group ◽  
Male Patients ◽  
The Difference ◽  
First Time

Background: The objective of the study was to compare the difference in pain scores during flexible cystoscopy between patients undergoing the procedure with insertion of the flexible cystoscope either immediately after topical lubrication with lignocaine gel or after a 3-minute delay.Methods: A total of 127 male patients with various indications for flexible cystoscopy were enrolled in this prospective study. Patients were randomized in two groups, immediate group and the delayed group depending on the retention time (immediate or after 3-minute delay) of the topical lignocaine gel. Pain scores were recorded immediately after the procedure using a visual analogue scale. The statistical analyses were performed using students “t” test.Results: Both the groups (immediate group and the delayed group) were comparable for variables including age, level of operating endoscopic surgeon and indication for the procedures. The most common indication for flexible cystoscopy was visible hematuria. There was no statistically significant difference in the mean pain scores between the two groups (p=0.98). However a small subset of patients (age less than 50 years), having flexible cystoscopy for the first time had less pain scores in the delayed group (p=0.003) but the sample size was very small.Conclusions: The study revealed that there appears to be no benefit in longer retention times of local anaesthetic during the outpatient flexible cystoscopy. However, there might be a possible advantage in men younger than 50 years of age who are having flexible cystoscopy for the first time.

A Randomised comparison and evaluation of I-gel, Supreme laryngeal mask airway and Ambu Auragain in Laparoscopic surgeries under general anaesthesia with controlled ventilation

2021 ◽  
Vol 12 (4) ◽  
pp. 68-75
Author(s):  
Meenakshi Sumadevi Pradeep ◽  
Niteen Khanderao Nandanwankar ◽  
Priya Vishwanath Lahane ◽  
Nazima Yusuf Memon ◽  
Shridhar Devidas Yennawar ◽  
...  
Keyword(s):  
General Anaesthesia ◽  
Primary Outcome ◽  
Supraglottic Airway ◽  
Randomised Study ◽  
Controlled Ventilation ◽  
Group I ◽  
Supraglottic Airway Devices ◽  
Significant Difference ◽  
Group A ◽  
Airway Devices

Background: Supraglottic airway devices (SAD) are becoming increasingly popular for use in patients undergoing laparoscopic surgeries. In this prospective randomised study, we compared three supraglottic airway devices namely, I-gel, Supreme LMA and Ambu Auragain. Aims and Objectives: The study was undertaken to compare three supraglottic airway devices I-gel, Supreme LMA and Ambu Auragain in laparoscopic surgeries under general anaesthesia with controlled ventilation. Materials and Methods: This was a randomized comparative study in which 90 patients undergoing laparoscopic surgeries under general anesthesia were included. In group A Ambu AuraGain was used whereas in group I and Group S I-gel and Supreme LMA was used respectively. Primary outcome measures which were compared amongst the studied groups included time taken for insertion, ease of insertion, attempts required for insertion, ease of insertion of Ryles tube, fiberoptic bronchoscopic grading and Oropharyngeal leak pressure. Results: There was highly significant difference in the time taken for insertion of SAD in Group-A when compared to Group- I (p<0.0001) and Group-S (p<0.0001). Group-A had significantly increased grades of ease of insertion of SAD when compared to Group-I (p=0.04) and Group-S (p=0.004). 16.66% of patients in Group-A required 3 attempts for successful insertion of the SAD, while no patients in Group- I or Group A required more than two attempts for insertion(p<0.05). Conclusion: Ambu AuraGain provides better oropharyngeal seal and has higher leak pressures as compared to I-gel and Supreme LMA with similar hemodynamic stability and post-operative outcome makingit a preferable SAD over I-gel and Supreme LMA.

A prospective randomised trial of absorbable versus non-absorbable sutures for wound closure after fasciectomy for Dupuytren’s contracture

2009 ◽  
Vol 34 (5) ◽  
pp. 618-620 ◽  
Author(s):  
K. HOWARD ◽  
A. J. M. SIMISON ◽  
A. MORRIS ◽  
V. BHALAIK
Keyword(s):  
Wound Closure ◽  
Wound Care ◽  
Randomised Trial ◽  
Dupuytren’S Contracture ◽  
Polyglactin 910 ◽  
Randomised Study ◽  
Dupuytren's Contracture ◽  
Prospective Randomised Trial ◽  
Absorbable Sutures ◽  
Significant Difference

After fasciectomy for Dupuytren’s contracture the wound has traditionally been closed with non-absorbable sutures. A prospective randomised study of 59 patients was undertaken to compare wound closure after fasciectomy with irradiated polyglactin 910 absorbable sutures and non-absorbable sutures. The outcomes studied were: time spent attending to the wound at the first postoperative visit; the patient’s pain score at that visit; and any complications. Wound care required significantly more time when non-absorbable sutures were used. There was no significant difference in pain scores or in complications between the two groups. We recommend the use of irradiated polyglactin 910 absorbable sutures for wound closure after fasciectomy as it saves time and resources without compromising wound healing.

L'anestesia combinata epidurale e generale versus l'anestesia generale nel paziente urologico anziano ad alto rischio. Uno studio clinico prospettico e randomizzato: Combined epidural and general anaesthesia versus general anaesthesia in high-risk urological elderly patients. A prospective randomised trial

1998 ◽  
Vol 65 (2) ◽  
pp. 212-214
Author(s):  
G. Galimberti ◽  
G. Berlot ◽  
F. Iscra ◽  
A. Gullo
Keyword(s):  
High Risk ◽  
General Anaesthesia ◽  
Randomised Trial ◽  
Anaesthetic Agents ◽  
Prospective Randomised Trial ◽  
Total Hospital Stay ◽  
Significant Difference ◽  
Complications And Mortality ◽  
To Receive ◽  
Blood Loss Volume

Twenty-eight elderly high-risk (ASA 3) patients undergoing elective major urological surgery were prospectively randomised to receive either combined epidural and general anaesthesia (CEGA) or general anaesthesia (GA). The use of intraoperative vasopressors was significantly higher in the CEGA group (p<0.001). There was no significant difference between groups with regard to blood loss, volume replacement, postoperative complications and mortality. The CEGA allowed saving of inhalatory anaesthetic agents (p<0.001) and a shorter total hospital stay than GA (p<0.0044). The authors conclude that the CEGA exerted a significant beneficial effect on the intraoperative outcome in a group of high-risk surgical patients.

scholarly journals Influence of two-handed jaw thrust during tracheal intubation on postoperative sore throat: a prospective randomised study

2021 ◽  
Vol 49 (2) ◽  
pp. 030006052096123
Author(s):  
Hyub Huh ◽  
Doo Yeon Go ◽  
Jang Eun Cho ◽  
Jihoon Park ◽  
Jiwon Lee ◽  
...  
Keyword(s):  
Tracheal Intubation ◽  
General Anaesthesia ◽  
Sore Throat ◽  
Randomised Trial ◽  
Control Group ◽  
Single Centre ◽  
Postoperative Sore Throat ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Randomised Study

Objective General anaesthesia with tracheal intubation results in sore throat. We evaluated the influence of the two-handed jaw thrust on postoperative sore throat in patients who require tracheal intubation. Methods In this prospective, double-blind, single-centre, parallel-arm, and randomised trial, 92 patients who were scheduled for general anaesthesia for total hip arthroplasty were allocated to one of two groups. In the jaw thrust group (n = 46), the two-handed jaw thrust manoeuvre was applied at intubation. In the control group (n = 46), conventional intubation with sham jaw thrust was performed. Incidences of airway morbidities including sore throat, hoarseness, and cough at 2, 4, and 24 hours postoperatively were compared. Results During the postoperative 24 hours, the incidence of sore throat (8 [17%] vs. 20 [44%]) and hoarseness were lower in the jaw thrust group (8 [17%] vs. 18 [39%]) compared with the control group. The incidence of cough during the postoperative 24 hours was similar between the groups. Conclusions The jaw thrust manoeuvre significantly reduced sore throat and hoarseness in patients after general anaesthesia using tracheal intubation. Clinical trial registration: NCT 03568279.

scholarly journals Comparative Study to Assess Paediatric Circumcision with the Plastibell Device Technique and Conventional Dissection Technique – A Prospective Randomised Trial

2020 ◽  
Vol 7 (45) ◽  
pp. 2645-2650
Author(s):  
Nilesh Parashuram Mangam ◽  
Lalit Vishvanath Tamgadge ◽  
Ashok Suryabhan Gajbhjye
Keyword(s):  
Average Rate ◽  
Randomised Trial ◽  
Late Complications ◽  
P Value ◽  
Age Group ◽  
Prospective Randomised Trial ◽  
Significant Difference ◽  
The Mean ◽  
The Difference ◽  
Dissection Technique

BACKGROUND Conventional Dissection Surgery (CDS) and Plastibell Device (PD) are the commonly used techniques for male circumcision. We wanted to evaluate and compare the postoperative problems and aesthetic results, and the patient’s / parent’s acceptance, of the two techniques of circumcision in boys. METHODS This was a prospective study in which children in the age group 0 - 12 years attending the surgery outpatient department for various indications of circumcision were enrolled on the basis of a predefined inclusion and exclusion criteria. The subjects were randomized and allocated into two groups, group PD and group CDS. Group PD was subjected to circumcision by Plastibell device technique. Group CDS was subjected to circumcision by conventional dissection technique. Duration of the circumcision and intra-operative complications if any were recorded, from starting the retraction of prepuce to completion of the procedure. Early and late complications were also compared during follow-up visits. Statistical analysis was performed using the Strata Software Version 10.0. P value less than 0.05 was taken as statistically significant. RESULTS The mean age of children in PD and CDS group was found to be 5.30 ± 3.29 years and 5.58 ± 3.66 years respectively. The mean age of patients in both the groups was found to be comparable with no statistically significant difference. According to Kayaba’s classification type 1 and type 2 (41.4 %) prepuce were most common in both the groups. Phimosis, ballooning of prepuce and recurrent urinary tract infection were common indications for circumcision in our study. Mean surgical time was 5.91 ± 1.74 in the P D group and 23.52 ± 5.94 in the CDS group which was statistically highly significant (P = 0.0000). Bleeding, cicatricial scar and adhesions were more common in CDS group, whereas dysuria and swelling were more common PD group and the difference was statistically significant. Children required less analgesia in CDS group. The average rate of late complications was significantly less in PD group as compared to CDS group (P = 0.006). CONCLUSIONS Circumcision by Plastibell device was comparable with conventional dissection technique in paediatrics age group. However, from aesthetic perspective, parents of Plastibell group appeared to be more satisfied than conventional dissection group. KEYWORDS Circumcision, Plastibell Device, Conventional Dissection Surgery, Complications

scholarly journals Safety and efficacy of fentanyl combined with midazolam in bronchoscopy under bispectral index-guided conscious sedation

2020 ◽  
Author(s):  
Qian He ◽  
Sujuan Zhang ◽  
Jun Zhou ◽  
Xiong Xu ◽  
Qianqian Xu ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Local Anesthesia ◽  
Bispectral Index ◽  
Conscious Sedation ◽  
Vital Signs ◽  
Transbronchial Biopsy ◽  
Endobronchial Ultrasound ◽  
Safety And Efficacy ◽  
Significant Difference ◽  
Vas Scores

Abstract Background: Sedation combined with local anesthesia during bronchoscopy is widely accepted in America and Europe, and receiving great attention in China. This study aimed to investigate the safety and efficacy of fentanyl combined with midazolam for bispectral index (BIS) titrated conscious sedation during bronchoscopy in the Chinese population. Methods: Data from 436 patients who underwent bronchoscopy under local anesthesia (LA group) or BIS-guided conscious sedation combined with local anesthesia (FM group) were retrospectively analyzed. The analysis included vital signs, adverse events recorded during the procedure, and questionnaire information, such as patient tolerance and satisfaction, operator satisfaction, and the cough score noted after the procedure. Results: A total of 225 patients in the LA group, and 211 in the FM group were enrolled in the study. The blood pressure and oxygen saturation were significantly higher in the LA group than in the FM group during bronchoscopy (P<0.001). The heart rate was significantly faster in the LA group at T3max, T3min and T4 than in the FM group. The incidence of hypoxia and bradycardia was higher in the FM group than in the LA group, whereas incidence of hypertension and tachycardia was lower. Patient satisfaction and tolerance of the procedure were significantly better in the FM group. visual analog scale (VAS) scores for cough and operator satisfaction were better in the FM group than in the LA group. Sub-group analysis (inspection, biopsy and transbronchial biopsy guided by radial endobronchial ultrasound (rEBUS-TBB)) indicated that the vital signs, adverse event(hypoxia) and patient satisfaction of the two groups were similar to the previous results. However, the VAS scores for operators’ satisfaction was no significant difference between the two groups in patients undergoing inspection. Conclusions: The conscious sedation regimen of fentanyl combined with midazolam monitored by BIS during bronchoscopy is safe and effective. Although the incidence of hypoxia and bradycardia was higher, the patient’s tolerance and physician’s satisfaction were significantly improved, especially during lengthy procedures, such as intrabronchial biopsy and transbronchial biopsy guided by radial endobronchial ultrasound. Trial registration: The study was approved by the ethics committee of Changzhou first people's Hospital (2019-020). Key words: bronchoscopy, bispectral index, conscious sedation, midazolam, fentanyl.

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