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In many countries, the combination of propofol and opioid is used as the preferred sedative regime during ERCP. However, the most serious risks of propofol sedation are oxygen deficiency and hypotension. Compared to midazolam, remimazolam has a faster onset and offset of hypnotic effect, as well as cardiorespiratory stability, and to achieve widespread acceptance for procedural sedation, remimazolam must replace propofol which is the most commonly used for procedural sedation. The objective of this study was to compare the safety and efficacy profiles of the remimazolam and propofol when combined with alfentanil for sedation during ERCP procedures. A randomized, controlled, single-center trial. The Endoscopic Centre of Tianjin Nankai Hospital, China. 518 patients undergoing elective ERCP under deep sedation. Patients scheduled for ERCP were randomly assigned to be sedated with either a combination of remimazolam-alfentanil or propofol-alfentanil. The primary outcome was the prevalence of hypoxia, which was defined as SpO2 < 90% for >10 s. Other outcomes were the need for airway maneuver, procedure, and sedation-related outcomes and side effects (e.g., nausea, vomiting, and cardiovascular adverse events). A total of 518 patients underwent randomization. Of these, 250 were assigned to the remimazolam group and 255 to the propofol group. During ERCP, 9.6% of patients in the remimazolam group showed hypoxia, while in the propofol group, 15.7% showed hypoxia (p = 0.04). The need for airway maneuvering due to hypoxia was significantly greater in the propofol group (p = 0.04). Furthermore, patients sedated with remimazolam had a lower percentage of hypotension than patients sedated with propofol (p < 0.001). Patients receiving remimazolam sedation expressed higher satisfaction scores and were recommended the same sedation for the next ERCP. The procedure time in the remimazolam group was much longer than in the propofol group due to the complexity of the patient's disease, which resulted in a longer sedation time. During elective ERCP, patients administered with remimazolam showed fewer respiratory depression events under deep sedation with hemodynamic advantages over propofol when administered in combination with alfentanil. •The combination of propofol and an opioid is the preferred sedative regime during ERCP.•The major concerns with propofol sedation include oxygen desaturation and hypotension.•Patients administered with remimazolam showed fewer respiratory depression events and hemodynamic advantages over propofol.•These results may provide more options for ERCP sedation.

AbstractObjectiveTo determine whether high flow nasal cannula (HFNC) oxygenation can reduce the incidence of hypoxia during sedated gastrointestinal endoscopy in patients with obesity.DesignMulticentre, randomised, parallel group trial.SettingThree tertiary hospitals in Shanghai, China.Participants1000 adult patients with obesity (body mass index ≥28) who were scheduled for gastrointestinal endoscopy.InterventionsParticipants were randomly allocated to receive regular nasal cannula oxygenation or HFNC oxygenation during a sedated procedure with propofol and low dose sufentanil.Main outcome measuresThe primary outcome was the incidence of hypoxia (75%≤SpO2<90% for <60 s) during the procedure. Secondary outcomes included the incidences of subclinical respiratory depression (90%≤SpO2<95% for any duration) and severe hypoxia (SpO2<75% for any duration or 75%≤SPO2<90% for >60 s) during the procedure.ResultsFrom 6 May 2021 to 26 May 2023, 984 patients (mean age 49.2 years; 36.9% (n=363) female) completed the study and were analysed. Compared with regular nasal cannula oxygenation, HFNC oxygenation reduced the incidence of hypoxia from 21.2% (103/487) to 2.0% (10/497) (difference −19.14, 95% confidence interval −23.09 to −15.36; P<0.001), subclinical respiratory depression from 36.3% (177/487) to 5.6% (28/497) (difference −30.71, −35.40 to −25.92; P<0.001), and severe hypoxia from 4.1% (20/487) to 0% (0/497) (difference −4.11%, −6.26 to −2.48; P<0.001). Other sedation related adverse events did not differ between the two groups.ConclusionsIn patients with obesity, oxygenation via HFNC during sedated gastrointestinal endoscopy significantly reduced the incidences of hypoxia, subclinical respiratory depression, and severe hypoxia without increasing other adverse events.Trial registrationClinicalTrials.gov NCT04500392.

AbstractObjectivesTo evaluate the effect of lateral versus supine positioning on incidence of hypoxaemia in sedated patients and to provide evidence based recommendations for respiratory strategies.DesignProspective, multicentre, randomised controlled trial.Setting14 tertiary hospitals in China, July to November 2024.Participants2159 adults (≥18 years) who underwent sedation.InterventionsSedated patients were randomly assigned (1:1) to receive either lateral positioning or conventional supine positioning, stratified by study centres.Main outcome measuresThe primary outcome was incidence of hypoxaemia (peripheral oxygen saturation (SpO2) ≤90%) within the first 10 minutes after positioning. Secondary outcomes included airway rescue interventions, incidence of severe hypoxaemia (SpO2 ≤85%), lowest oxygen saturation recorded, length of stay in the post-anaesthesia care unit, and safety measures (eg, bradycardia, tachycardia, hypotension, new onset arrhythmia). Analyses were performed on an intention-to-treat basis.ResultsOf 2159 patients randomised, 2143 were included in the primary analysis. The mean age of the patients was 53.1 years, mean body mass index was 23.9, and 53.7% (1150/2143) were women. The incidence of hypoxaemia was significantly lower in the lateral group compared with supine group (5.4% (58/1073) v 15.0% (161/1070); adjusted risk ratio 0.36, 95% confidence interval (CI) 0.27 to 0.49; P<0.001). Compared with patients in the supine group, patients in the lateral group required fewer airway rescue interventions (6.3% (68/1073) v 13.8% (148/1070); adjusted risk ratio 0.46, 0.34 to 0.61; P<0.001), had a lower incidence of severe hypoxaemia (0.7% (8/1073) v 4.8% (51/1070); adjusted risk ratio 0.16, 0.07 to 0.33; P<0.001), and had a higher mean lowest SpO2 level (96.9% v 95.7%, absolute adjusted mean difference 1.20%, 95% CI 0.87% to 1.54%; P<0.001). Additionally, length of stay in the post-anaesthesia care unit was shorter in the lateral group (38.2 v 40.5 minutes; absolute adjusted mean difference −2.22 minutes; 95% CI −3.63 to −0.80; P=0.002). Safety outcomes were comparable between the groups, but tachycardia was less frequent in the lateral group.ConclusionsPlacing sedated adults in the lateral position significantly reduces the incidence and severity of hypoxaemia and decreases the need for airway rescue interventions without compromising safety. Given its simplicity and low cost, lateral positioning could offer advantages in remote or resource constrained clinical settings. Further replication studies targeting patients with advanced age and high body mass index are needed to improve the generalisability of the findings.Trial registrationClinicalTrials.gov NCT06459167.

Dexmedetomidine improves intrapulmonary shunt in thoracic surgery and minimizes inflammatory response during one-lung ventilation (OLV). However, it is unclear whether such benefits translate into less postoperative pulmonary complications (PPCs). Our objective was to determine the impact of dexmedetomidine on the incidence of PPCs after thoracic surgery. Major databases were used to identify randomized trials that compared dexmedetomidine versus placebo during thoracic surgery in terms of PPCs. Our primary outcome was atelectasis within 7 days after surgery. Other specific PPCs included hypoxemia, pneumonia, and acute respiratory distress syndrome (ARDS). Secondary outcome included intraoperative respiratory mechanics (respiratory compliance [Cdyn]) and postoperative lung function (forced expiratory volume [FEV1]). Random effects models were used to estimate odds ratios (OR). Twelve randomized trials, including 365 patients in the dexmedetomidine group and 359 in the placebo group, were analyzed in this meta-analysis. Patients in the dexmedetomidine group were less likely to develop postoperative atelectasis (2.3% vs 6.8%, OR 0.42, 95%CI 0.18–0.95, P = 0.04; low certainty) and hypoxemia (3.4% vs 11.7%, OR 0.26, 95%CI 0.10–0.68, P = 0.01; moderate certainty) compared to the placebo group. The incidence of postoperative pneumonia (3.2% vs 5.8%, OR 0.57, 95%CI 0.25–1.26, P = 0.17; moderate certainty) or ARDS (0.9% vs 3.5%, OR 0.39, 95%CI 0.07–2.08, P = 0.27; moderate certainty) was comparable between groups. Both intraoperative Cdyn and postoperative FEV1 were higher among patients that received dexmedetomidine with a mean difference of 4.42 mL/cmH2O (95%CI 3.13–5.72) and 0.27 L (95%CI 0.12–0.41), respectively. Dexmedetomidine administration during thoracic surgery may potentially reduce the risk of postoperative atelectasis and hypoxemia. However, current evidence is insufficient to demonstrate an effect on pneumonia or ARDS. •Translational research has demonstrated that dexmedetomidine minimizes inflammatory response during one-lung ventilation.•Our meta-analysis aimed to determine whether dexmedetomidine reduces pulmonary complications after thoracic surgery.•Dexmedetomidine administration reduces atelectasis and improves oxygenation in the postoperative period.•The current evidence is not sufficient to demonstrate any effect of dexmedetomidine on postoperative pneumonia.•A large, randomized trial is warranted to further clarify the potential benefit of dexmedetomidine on pulmonary outcomes

Hypoxemia is one of the most frequent adverse events during sedated gastroscopy, and there is still no effective means to prevent and cure it. Therefore, we conducted this randomized trial to confirm our hypothesis that, compared with the nasal cannula group, bilevel positive airway pressure (BPAP) would decrease the incidence of hypoxemia in patients with obstructive sleep apnea (OSA) or overweight status undergoing gastroscopy. In a single-center, prospective, randomized controlled clinical trial, 80 patients aged 18–65 years and with OSA or overweight status who underwent gastroscopy with sedation were randomly assigned to two groups: the nasal cannula and BPAP groups. The primary outcome was the incidence of hypoxemia (75% < peripheral oxygen saturation [SpO2] < 90% for >5 sand <60 s). Compared to the nasal cannula group, BPAP therapy significantly decreased the incidence of hypoxemia from 40.0% to 2.5% (absolute risk difference [ARD], 37.5% [95% confidence interval (CI), 21.6 to 53.4], p < 0.001), decreased subclinical respiratory depression from 52.5% to 22.5% (ARD, 30.0% [95% CI, 9.8 to 50.2], p = 0.006), and decreased severe hypoxemia from 17.5% to 0% (ARD, 17.5% [95% CI, 5.7 to 29.3], p = 0.006). The BPAP intervention also decreased the total propofol dosage and operation time and improved anesthesiologist's satisfaction. BPAP therapy significantly decreased the incidence of hypoxemia in patients with OSA or overweight status who underwent gastroscopy. •Hypoxemia is one of the most frequent adverse events during sedated gastroscopy.•Bilevel positive airway pressure therapy significantly decreased the incidence of hypoxemia during gastroscopy.•Bilevel positive airway pressure is expected to become an alternative ventilation method in patients at risk of hypoxemia.

Background Transnasal humidified rapid-insufflation ventilatory exchange is a novel ventilation modality which can provide very high flow (up to 70 l/min) heated and humidified gas with adjustable temperatures (31–37 °C) and oxygen concentrations (21–100%). However its application in sedated gastroscopy in children has received little attention. Objective To observe transnasal humidified rapid-insufflation ventilatory exchange in sedated gastroscopy in children and its effect on the incidence of hypoxemia. Design A prospective randomized clinical trial. Setting Endoscopy Center in Shenzhen Children’s Hospital. Patients 120 children (ASA grade I–II), aged 6–12 years with a body mass index of 18–25 kg m-2, who underwent sedated gastroscopy at Shenzhen Children’s Hospital between June 2022 and November 2022. Interventions The participants were randomly assigned in a 1:1 ratio to receive transnasal humidified rapid-insufflation ventilatory exchange or nasal cannula oxygen therapy. Main outcome measures The primary outcome was hypoxemia incidence. The secondary outcomes included the lowest oxygen saturation index, duration of hypoxemia, incidence of adverse respiratory conditions, intervention rate, and endoscopist satisfaction. Results Five children (8.3%) in thetransnasal humidified rapid-insufflation ventilatory exchange group had hypoxemia compared with 17 (28.3%) in the nasal cannula group, with a significant difference (P<0.01). The lowest oxygen saturation index in two groups shows no significant difference [98 (95, 99) vs. 98 (90, 99), P=0.087]. However compared with the nasal cannula group, the duration of hypoxaemia was significantly shorter (9.00 ± 1.73 s vs. 13.18 ± 3.49 s, 95% CI -6.63 to -1.72; P<0.01), the intervention rate was significantly lower (n=7, 11% vs. n=18, 30%; P<0.05), the incidence of adverse breathing complications was significantly lower (n=8, 13.3% vs. n=18, 30%; P<0.05), and the satisfaction of endoscopists was significantly higher (88.3% vs. 68.3%, P<0.05) in the transnasal humidified rapid-insufflation ventilatory exchange group. Conclusion Transnasal humidified rapid-insufflation ventilatory exchange can promote oxygenation reducing the incidence of hypoxemia in sedated gastroscopy in children. Trial registration ChiCTR2200060799. Key points - THRIVE can reduce the work of breathing and improve oxygenation in children. - THRIVE can provide positive respiratory and continuous positive airway pressure, thereby promoting end-respiratory alveolar dilation. - THRIVE ensures oxygenation during short duration paediatric gastroscopy.

Background By continually monitoring end-tidal carbon dioxide concentrations, capnography can detect abnormal ventilation or apnoea early. This randomized, controlled study explored the effect of early intervention with capnography on the incidence of hypoxia in mildly obese patients undergoing sedation for esophagogastroduodenoscopy (EGD) and colonoscopy. Methods This is a single-center, randomized, single-blind, parallel-assignment, controlled trial. Mildly obese patients (28 kg/m 2  ≤ BMI < 40 kg/m 2 ) undergoing sedation for EGD and colonoscopy were randomly assigned to either the standard or capnography group. Standard cardiopulmonary monitoring equipment was used in both groups, and additional capnography was performed in the capnography group. In the event of inadequate alveolar ventilation during sedation, five interventions were administered in sequence (a-e) : a: increasing oxygen flow (5 L/min); b: a chin lift or jaw thrust maneuver; c: placement of the nasopharyngeal airway and chin lift; d: mask positive-pressure ventilation, and e: ventilator-assisted ventilation with tube insertion. The primary outcome was the incidence of hypoxia (SpO 2  < 90%, ≥ 10 s) in each group. The secondary outcomes included the incidence of severe hypoxia (SpO 2  ≤ 85%), subclinical respiratory depression (90% ≤ SpO 2  < 95%), interventions, minimum SpO 2 during operation, patient satisfaction, endoscopist satisfaction, and other adverse events of anesthesia sedation. Results 228 patients were included (capnography group = 112; standard group = 113; three patients were excluded) in this study. The incidence of hypoxia was significantly lower in the capnography group than in the standard group (13.4% vs. 30.1%, P  = 0.002). Subclinical respiratory depression in the capnography group was higher than that of the standard group (30.4% vs. 17.7%, P  = 0.026). There was only a 5.4% incidence of severe hypoxia in the capnography group compared with 14.2% in the standard group ( P  = 0.026). During sedation, 96 and 34 individuals in the capnography and standard groups, respectively, underwent the intervention. There was a statistically significant difference ( P  < 0.0001) in the number of the last intraoperative intervention between the two groups ( a:47 vs. 1, b:46 vs. 26, c:2 vs. 5, d:1 vs. 2, e:0 vs. 0 ). No significant differences were found between the two groups in terms of minimum SpO 2 during operation, patient satisfaction, or endoscopist satisfaction rating. There was no statistically significant difference in adverse events of anesthesia sedation between the two groups. Conclusion Capnography during sedation for EGD and colonoscopy allows for the detection of apnea and altered breathing patterns in mildly obese patients before SpO 2 is reduced. Effective intervention measures are given to patients within this time frame, which reduces the incidence of hypoxia and severe hypoxia in patients. Trial registration Ethical approval was granted by the Medical Ethics Committee (Chairperson Professor Tian Hui) of Qilu Hospital, Shandong University ((Ke) Lun Audit 2021 (186)) on 15/07/2021. The study was registered ( https://www.chictr.org.cn ) on 23/10/2021(ChiCTR2100052234). Designed and reported using CONSORT statements.

Background The randomized controlled trial, TRAUMOX2, compared early restrictive vs. liberal oxygen strategies for trauma patients. The objective of this substudy was to quantify the occurrence and duration of hypoxemic episodes during the trial’s eight-hour intervention. Methods This observational substudy analyzed a subset of patients at two trial sites in Denmark. Continuous pulse oximetry recorded arterial oxygen saturation (SpO 2 ) during the intervention. The primary outcome was the proportion of patients who had episodes of hypoxemia with SpO 2  < 90% for at least five minutes. Additionally, the study assessed differences in the occurrence and duration of hypoxemia between the restrictive and liberal oxygen groups. Results This substudy included 82 patients. After secondary exclusion, 60 patients (median age, 49 years [interquartile range 33–61] and 75% male) were analyzed. Three out of 60 patients (5%) had at least one episode of SpO 2  < 90% for at least five minutes (95% confidence interval 1–14%); Two patients in the restrictive oxygen group and one in the liberal oxygen group. Two episodes occurred during initial resuscitation, and one episode occurred in the intensive care unit following a procedure related to thoracic injuries. Conclusions In this substudy of 60 patients from the TRAUMOX2 trial, hypoxemia (SpO 2  < 90% for at least five minutes) was observed in 5% of patients, with no difference between the restrictive and liberal oxygen groups. These findings suggest that, among trauma patients not already requiring continuous monitoring, such episodes of hypoxemia are relatively rare early post-trauma.

BackgroundIn obese patients (OP), the best intraoperative ventilation strategy remains to be defined. Dynamic lung compliance (Cdyn) and dead space fraction are indicators of efficient ventilation at an optimal positive end-expiratory pressure (PEEP). Herein, we investigated whether intraoperative dynamic lung compliance optimization through PEEP manipulations affects the incidence of postoperative hypoxemia (SpO2 < 90%) in OP undergoing laparoscopic bariatric surgery (LBS).MethodsThis was a single-center, prospective, randomized controlled study conducted from July 2013 to December 2015. After obtaining institutional review board approval and informed consent, 100 OP undergoing LBS under volume-controlled ventilation (tidal volume 8 mL/kg of ideal body weight) were randomized according to the PEEP level maintained during the surgery. In the control group, a PEEP of 10 cm H2O was maintained, while in the intervention group, the PEEP was adapted to achieve the best dynamic lung compliance. Anesthesia and analgesia were standardized. The patients received supplemental nasal oxygen on the first postoperative day and were monitored up to the second postoperative day with a portable pulse oximeter.ResultsDemographics were similar between groups. There was no difference in the incidence of hypoxemia during the first 2 postoperative days (control: 1.3%; intervention: 2.1%; p = 0.264).ConclusionsThe incidence of postoperative hypoxemia was not reduced by an open-lung approach with protective ventilation strategy in obese patients undergoing LBS. A pragmatic application of a PEEP level of 10 cm H2O was comparable to individual PEEP titration in these patients.Trial RegistrationClinicaltrials.gov identifier, NCT02579798; https://clinicaltrials.gov/ct2/show/NCT02579798

Background Hypoxemia is the most common adverse reaction during sedated hysteroscopy. Obesity is a risk factor for hypoxemia. For hysteroscopy, propofol is the most commonly used sedative. However, it can cause dose-dependent respiratory depression. This drawback has driven the search for sedatives with less respiratory depressant effects. Remimazolam is a new benzodiazepine drug with several advantages, including minimal impact on the respiratory and circulatory systems. This study aims to compare remimazolam and propofol in terms of safety and efficacy in patients with overweight or obesity who are undergoing sedated hysteroscopy. Methods This prospective, single-center, randomized, single-blind, controlled clinical trial will be conducted to examine the effect of remimazolam on the incidence of severe hypoxemia in patients with overweight or obesity. Patients ( n  = 600) scheduled to undergo sedated hysteroscopy will be randomly assigned to either the control or experimental group and will be sedated using propofol or remimazolam, respectively. Discussion The main objective of this study is to determine whether remimazolam can reduce the incidence of severe hypoxemia in patients with overweight or obesity during hysteroscopy. The results of this study are expected to provide evidence on the safety and efficacy of remimazolam in patients with overweight or obesity, which will enhance patient comfort and safety during sedated hysteroscopy. Trial registration ClinicalTrials.gov NCT06187896. Registered on January 3, 2024.