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Objective: Remimazolam is a novel benzodiazepine sedative that provides effective sedation, stable haemodynamics, and minimal adverse effects during intravenous general anaesthesia. The aim of this study was to determine the 50% effective dose (ED50) of remimazolam combined with different doses of esketamine for painless gastroscopy and to evaluate the efficacy and safety of this combination. Methods: This was a randomised, double-blind, up-and-down sequential allocation study. Patients undergoing painless gastroscopy who met all the inclusion criteria and did not meet any of the exclusion criteria were randomised in a 1:1:1 ratio into the ES0 group (0 mg/kg of esketamine), ES1 group (0.2 mg/kg of esketamine), and ES2 group (0.4 mg/kg of esketamine). The initial dose of remimazolam was 0.3 mg/kg in each group, with the dose increased or decreased by 0.05 mg/kg for the subsequent patient based on the success or failure of sedation in the previous patient. The trial was concluded when seven successful failure crossovers were achieved. The ED50 and 95% confidence intervals (CI) of remimazolam were calculated using Probit regression. Haemodynamic parameters, time to induction of anaesthesia, time to gastroscopy, time to awakening from anaesthesia, and adverse events were recorded. Results: A total of 59 patients were included in the final analysis: 19 in the ES0 group, 23 in the ES1 group, and 17 in the ES2 group. The ED50 (95% CI) of remimazolam in the ES0, ES1, and ES2 groups was 0.344 (0.302–0.389) mg/kg, 0.289 (0.249–0.328) mg/kg, and 0.193 (0.145–0.239) mg/kg, respectively. Additionally, the ES1 and ES2 groups exhibited more stable haemodynamics compared to the ES0 group. However, the ES1 and ES2 groups had significantly longer recovery times than the ES0 group. The incidence of hypotension was higher in the ES0 group compared to the ES1 and ES2 groups. Conclusion: The ED50 of remimazolam combined with 0 mg/kg, 0.2 mg/kg, and 0.4 mg/kg of esketamine for induction of anaesthesia during painless gastroscopy was 0.344 mg/kg, 0.289 mg/kg, and 0.193 mg/kg, respectively. Combining esketamine with remimazolam for induction of anaesthesia during painless gastroscopy offers advantages in terms of haemodynamic stability and reduced adverse effects.

Background/objectives: This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention. Subjects/methods: In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30–40 kg m − 2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss. Results: At 6 months, weight loss was −3.3% of total body weight (−3.2 kg) in the lifestyle arm vs −10.2% (−9.9 kg) in the balloon plus lifestyle arm ( P <0.001); at 9 months (3 months postballoon removal), weight loss was −3.4% (−3.2 kg) vs −9.1% (−8.8 kg, P ⩽0.001); and at 12 months, −3.1% (−2.9 kg) vs −7.6% (−7.4 kg, P ⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) ( P =0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group ( P <0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found. Conclusions and relevance: Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

Patients with obesity are more susceptible to hypoxemia. Anesthetic management for patients with obesity undergoing painless gastroscopy presents a severe challenge for anesthesiologists. Esketamine is a NMDA antagonist that has been proven to be beneficial for ameliorating respiratory depression owing to its sympathomimetic effect; however, there are no relevant reports on its use in patients with obesity. We designed a randomized controlled trial to evaluate whether esketamine can be the ideal adjuvant to propofol sedation in patients with obesity undergoing painless gastroscopy. A total of 104 patients with obesity undergoing painless gastroscopy were randomly divided into group C (propofol+saline) and group S (propofol+esketamine 0.25 mg/kg). Anesthesia was induced by 2 mg/kg propofol with saline or esketamine. The consumption of propofol, hemodynamic parameters, duration of procedure, induction time, postoperative awakening time, and orientation recovery time were recorded. Adverse events and satisfaction scores were also recorded. Propofol consumption was 274.4±22.6 mg and 201.3±16.6 mg in groups C and S, respectively. The induction time of groups C and S were 25.4±2.3 s and 17.8±1.9 s, respectively. The postoperative awakening times of groups C and S were 6.2±1.1 min and 4.8±1.3 min, respectively. Hemodynamic parameters were more stable in group S than in group C. The incidence of adverse events such as injection pain, hypoxemia, hypotension, bradycardia, choking, and body movement were significantly lower in group S. The satisfaction scores of the endoscopist and anesthesiologist were (4.58±0.49 vs 3.71±0.83) and (4.75±0.44 vs 3.33±0.92), respectively. The combination of propofol and esketamine (0.25 mg/kg) improves the safety and reduces the incidence of adverse events in patients with obesity during painless gastroscopy. Thus, this method is worthy of clinical application. ChiCTR 2200062547.

Objective To clarify the effectiveness of second-look endoscopy (SLE) at preventing bleeding after gastric endoscopic submucosal dissection (ESD). Design A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan. Patients with a solitary gastric neoplasm were enrolled. Exclusion criteria were previous oesophagogastric surgery or radiation therapy; perforation and the administration of antithrombotics, steroids or non-steroidal anti-inflammatory drugs. Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor. SLE was performed one day after ESD. The primary endpoint was post-ESD bleeding, defined as an endoscopically proven haemorrhage. The trial had the power to detect a non-inferiority criterion of 7% between the groups. Results From February 2012 to February 2013, 130 and 132 patients were assigned to the SLE and the non-SLE groups, respectively. All patients were included in the intention-to-treat analysis of the primary endpoint. Post-ESD bleeding occurred in seven patients with (5.4%) SLE and five patients with (3.8%) non-SLE (risk difference −1.6% (95% CI −6.7 to 3.5); pnon-inferiority<0.001), meeting the non-inferiority criterion. All 12 patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment. Conclusions SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk. Trial registration number UMIN-CTR000007170.

A post-marketing, parallel-controlled clinical trial (REST trial) was conducted to evaluate the safety and efficacy of cipepofol versus propofol for the induction of anesthesia/sedation in Chinese elderly patients undergoing gastroscopy. All enrolled patients aged ≥65 years were assigned randomly in a 1:1 ratio to be administered intravenous cipepofol-0.3 mg/kg or propofol-1.5 mg/kg. The primary endpoint was incidence of respiratory-related adverse events (AEs) including respiratory depression (respiratory rate < 8 breaths/min lasting for >30 s), apnea (loss of thoracic movement for >15 s) and hypoxemia (SpO2 < 93 % lasting for >15 s). Secondary endpoints included: success rates of the gastroscopy procedure and gastroscope insertion; gastroscopy-related duration (successful anesthesia/sedation induction duration; time to full alertness; time to leaving the post-anesthesia care unit; gastroscope insertion duration); satisfaction rate for the anesthesia/sedation process and anesthetics. Among 890 randomized patients, 871 were finally included in the full analysis set (FAS), with 431 receiving cipepofol and 440 receiving propofol. Patients treated with cipepofol had a significantly lower incidence of respiratory-related AEs compared to propofol treatment (FAS: 22.3 % vs. 33.9 %, per-protocol set: 20.6 % vs. 34.5 %, all P < 0.001), regardless of sex. Multivariable analysis revealed that the risk of patients experiencing respiratory-related AEs was 1.82 times higher in the propofol group compared to cipepofol group (P < 0.001). The success rates of the gastroscopy procedure and gastroscope insertion were both 100 % in the two groups. Gastroscopy procedure-related durations were shorter in propofol group compared to cipepofol group (all P < 0.05). Patients treated with cipepofol exhibited a significantly lower rate of treatment-emergent AEs (TEAEs) (55.0 % vs. 67.7 %, P < 0.001), TEAEs of special interest (53.4 % vs. 65.2 %, P < 0.001) and injection pain (2.6 % vs. 28.4 %, P < 0.001). Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy, especially complimented by lower incidences of respiratory-related AEs and injection pain. Clinical trials registration: Chinese Clinical Trial Registry, ChiCTR2100052299, registered on October 24, 2021. [Display omitted] •Safety and the efficacy of cipepofol vs propofol for the induction of anesthesia/sedation during gastroscopy were evaluated.•Cipepofol group showed significantly lower incidences of respiratory-related adverse events and injection pain.•Success rates of the gastroscopy procedure and gastroscope insertion were both 100 % between groups.•Gastroscopy procedures-related durations were shorter in the propofol group compared to the cipepofol group.•Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy.

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 Propofol sedation in patients with Obstructive Sleep Apnea (OSA) frequently induces hypoxemia, posing significant clinical risks. Esketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, may reduce propofol requirements while preserving respiratory stability, but its efficacy in OSA patients remains unproven. At the studied dose (0.25 mg/kg), esketamine’s potential side effects (transient hypertension) are expected to be mild and self-limited. Therefore, we aimed to test whether low-dose esketamine (0.25 mg/kg) can reduce the incidence of hypoxemia in moderate-to-high risk OSA patients during propofol-based painless gastroscopy. Methods This single-center, double-blind, randomized controlled superiority trial will enroll 294 patients (STOP-Bang score ≥ 3, 18–90 years, STOP-Bang = Snoring, Tiredness, Observed apnea, Pressure [blood], Body Mass Index [BMI], Age, Neck size, Gender.) undergoing gastroscopy. Participants will be randomized 1:1 to receive either esketamine (0.25 mg/kg) plus propofol or saline placebo plus propofol, stratified by age (18–65 vs. > 65 years) and OSA severity (STOP-Bang 5–6 vs. ≥ 7). The primary outcome is the incidence of hypoxemia (Peripheral Oxygen Saturation [SpO 2 ] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO 2  ≤ 75% or ≤ 90% for ≥ 60 s), duration of hypoxemia, emergency airway management, propofol consumption, hemodynamic stability, involuntary body movements, procedure/recovery times, and clinician satisfaction (measured via 10-cm Visual Analog Scale [VAS]). Discussion This protocol rigorously evaluates esketamine’s potential to improve sedation safety in OSA patients, addressing a critical gap in peri-procedural care. Trial registration Chinese Clinical Trial Registry (ChiCTR2500099420). Registered on March 24, 2025 (Supplementary File 2). Si-Qi Hao is a co-first author with the same contribution as the first author. The corresponding author is Li-Xin An.

Current gastroscopy practices necessitate a balance between procedural efficiency and patient safety. It has been hypothesized that increasing procedure outcomes through the use of Streptomyces protease enzyme and Shutai is possible; however, precise nature of any potential adverse reactions and complications remains unknown. In Zhanjiang, China, 213 patients undergoing gastroscopy participated in this controlled trial. The subjects were allocated at random into two groups: control and treatment. The treatment group was administered topical Streptomyces protease enzyme and intravenous Shutai. Using chi‐square and t‐tests, information regarding patient demographics, adverse reactions, wound healing, procedure duration, distress levels, and satisfaction was gathered and analysed. The demographic and medical history characteristics of the groups were comparable. There was a greater prevalence of modest immediate reactions in the treatment group (p < 0.05), whereas there were no significant variations observed in delayed reactions and long‐term complications (p > 0.05). The treatment group exhibited superior efficiency metrics, including shorter durations for diagnosis, procedure completion and recuperation (p < 0.05). The treatment group exhibited significantly higher patient satisfaction scores (p < 0.05). The incorporation of Streptomyces protease enzyme and Shutai into gastroscopy procedures resulted in significantly enhanced level of procedural efficacy and patient contentment while not introducing an additional risk of long‐term complications. The increase in moderate immediate reactions that have been observed requires additional research in order to determine their clinical significance. Although these agents present a possible progression in the field of gastroscopy, their application should be tempered by the immediate adverse reactions that have been documented.

IntroductionDuring sedation for gastroscopy, hypoxaemia represents the most common adverse event. The objective of this trial is to assess the efficacy and safety of bilevel positive airway pressure (BPAP) for the prevention of hypoxaemia, in comparison with nasal cannula oxygen therapy, among patients predisposed to hypoxaemia during sedation for gastroscopy.Methods and analysisThis randomised controlled trial (RCT) will include 616 patients at risk of hypoxaemia when undergoing gastroscopy, including those with advanced age, frailty, American Society of Anesthesiologists grades III–IV, obesity, obstructive sleep apnoea–hypopnoea syndrome, cardiac disease, respiratory disease and diabetes. The patients will be randomly assigned to either the BPAP or nasal cannula group in a 1:1 ratio. The primary analysis for this study will use the modified intention-to-treat analysis set. The primary outcome is defined as the incidence of hypoxaemia (SpO275%–90%, duration 5–60 s). Outcomes data will be compared using the χ2 or Fisher’s exact tests. Effect sizes will be used to assess the clinical effects of the intervention using absolute risk differences and 95% CIs. To assess the efficacy of BPAP in different patient subgroups, analyses will be performed based on clinical characteristics and risk factors associated with hypoxaemia.Ethics and disseminationThe Ethics Committee of the First Affiliated Hospital of Zhengzhou University reviewed and approved this RCT (Scientific Research Ethics Review: 2023-KY-0815-003). Subsequently, the outcome will be published in peer-reviewed journals.Trial registration numberChiCTR2400084596.