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Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial.

ABSTRACT: Importance:Hypnosis is now widespread in medical practice and is emerging as an alternative technique for pain management and anxiety. However, its effects on postoperative outcomes remain unclear. Objective:To evaluate the efficacy of a preoperative hypnosis session for reducing postoperative breast pain in patients who underwent minor breast cancer surgery. Design, Setting, and Participants:The HYPNOSEIN prospective randomized clinical trial was conducted from October 7, 2014, to April 5, 2016. In this multicenter study in France, 150 women scheduled for minor breast cancer surgery were randomized between control and hypnosis arms, and 148 (71 control and 77 hypnosis) were included in the intent-to-treat analysis. Intervention:On the day of surgery, eligible patients were randomly assigned (1:1) to the control arm or the hypnosis arm. Patients (but not the care teams) were blinded to the arm to which they were assigned. A 15-minute hypnosis session before general anesthesia in the operating room was performed in the hypnosis arm. Main Outcomes and Measures:The primary end point was breast pain reduction (by 2 on a visual analog scale), assessed immediately before discharge from the postanesthesia care unit (PACU). Secondary end points were nausea/vomiting, fatigue, comfort/well-being, anxiety, and PACU length of stay, assessed at different times until postoperative day 30. Results:The median patient age was 57 years (range, 33-79 years) in the control arm and 53 years (range, 20-84 years) in the hypnosis arm. Baseline characteristics were similar in the 2 arms. The median duration of the hypnosis session was 6 minutes (range, 2-15 minutes). The use of intraoperative opioids and hypnotics was lower in the hypnosis arm. The mean (SD) breast pain score (range, 0-10) was 1.75 (1.59) in the control arm vs 2.63 (1.62) in the hypnosis arm (P?=?.004). At PACU discharge and with longer follow-up, no statistically significant difference in breast pain was reported. Fatigue was significantly lower in the hypnosis arm on the evening of surgery (mean [SD] score, 3.81 [2.15] in the control arm vs 2.99 [2.56] in the hypnosis arm; P?=?.03). The median PACU length of stay was 60 minutes (range, 20-290 minutes) in the control arm vs 46 minutes (range, 5-100 minutes) in the hypnosis arm (P?=?.002). Exploratory analyses according to patient perception of whether she received hypnosis showed significantly lower fatigue scores in the perceived hypnosis subgroup on the evening of surgery (mean [SD], 4.13 [2.26] for no perceived hypnosis vs 2.97 [2.42] for perceived hypnosis; P?=?.01). Anxiety was also significantly lower on the evening of surgery in the perceived hypnosis subgroup (mean [SD], 0.75 [1.64] for perceived hypnosis vs 1.67 [2.29] for no perceived hypnosis; P?=?.03). Conclusions and Relevance:The results of this study do not support a benefit of hypnosis on postoperative breast pain in women undergoing minor breast cancer surgery. However, other outcomes seem to be improved, which needs to be confirmed by further studies. Trial Registration:EudraCT Identifier: 2014-A00681-46 and ClinicalTrials.gov Identifier: NCT03253159.

SUBMITTER: Amraoui J

PROVIDER: S-EPMC6324272 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Project description:BackgroundAbnormal cardiac repolarization, indicated by a prolongation of the QT interval, increases the risk for torsades de pointes, a potentially life-threatening arrhythmia. Many perioperatively administered drugs and conditions prolong the QT interval. Despite several reports of perioperative torsades de pointes, systematic evidence regarding perioperative QT interval prolongation is limited.MethodsSerial postoperative 12-lead electrocardiograms were obtained from 469 adult patients undergoing major noncardiac surgery under general anesthesia. Heart rate corrected QT-interval duration (Fridericia formula) was the primary outcome. All perioperatively administered drugs were recorded. Emphasis was placed on absolute QTc prolongation greater than 500 ms and relative increases of 30 and 60 ms.ResultsAt the end of surgery, 80% of the patients (345 of 429) experienced a significant QTc interval prolongation (ΔQTc 23 ± 26 ms (mean and SD), 95% CI 20-25 ms, P less than 0.001). Approximately 51% (219 of 429) had a QTc greater than 440 ms, and 4% (16 of 429) a QTc greater than 500 ms. In 39% (166 of 429), the ΔQTc was greater than 30 ms, in 8% (34 of 429) >60 ms, and in greater than 0.5% (2 of 429) >100 ms. No changes in ΔQTc occurred at subsequent time points. One patient developed torsades de pointes with a ΔQTc: 29 ms (0.4% incidence rate). Several drugs had a large effect on ΔQTc: isoflurane, methadone, ketorolac, cefoxitin, zosyn, unasyn, epinephrine, ephedrine, and calcium. Postoperative body temperature had a weak negative correlation with ΔQTc (r = -0.15, P = 0.02); serum magnesium, potassium, and calcium concentrations were not correlated.ConclusionPostoperative QT-interval prolongation is common. Several perioperatively administered drugs are associated with a substantial QT-interval prolongation. The exact cause and its clinical relevance are, however, unclear. Nevertheless, an association between postoperative QT prolongation and risk for torsades de pointes is likely.

Project description:BackgroundThe EasyTube® (EzT) is a supraglottic airway device (SAD) enabling ventilation irrespective of its placement into the esophagus or trachea. Data obtained on SADs from multicenter studies, performed in highly specialized centers cannot always be transferred to other sites. However, data on comparability of different sites are scarce. This study focused on inter-site variability of ventilatory and safety parameters during general anesthesia with the EzT.Methods400 patients with ASA physical status I-II undergoing general anesthesia for elective surgery in four medical centers (EzT group (n = 200), ETT group (n = 200)). Mallampati classification, success of insertion, insertion time, duration of ventilation, number of insertion attempts, ease of insertion, tidal volumes, leakage, hemodynamic parameters, oxygenation, and complications rates with the EasyTube (EzT) or endotracheal tube (ETT) in comparison within the sites and in between the sites were recorded.ResultsIntra-site and inter-site comparison of insertion success as primary outcome did not differ significantly. The inter-site comparison of expiratory minute volumes showed that the volumes achieved over the course of anesthesia did not differ significantly, however, mean leakage at one site was significantly higher with the EzT (0.63 l/min, p = 0.02). No significant inter-site differences in heart rate, blood pressure, or oxygenation were observed. Sore throat and blood on the cuff after removal of the device were the most frequent complications with significantly more complications at one site with the EzT (p = 0.01) where insertion was also reported significantly more difficult (p = 0.02).ConclusionPerformance of the EzT but not the ETT varied between sites with regard to insertion difficulty, leakage, and complications but not insertion success, ventilation, hemodynamics, and oxygenation parameters in patients with ASA physical status 1-2 during general anesthesia undergoing minor elective surgery.

Project description:Sleep disorder dramatically affects people's physical and mental health. Here, we investigated the effect of preoperative sleep disorders on anesthesia recovery and postoperative pain in patients undergoing laparoscopic gynecological surgery under general anesthesia. 120 patients who underwent elective laparoscopic gynecological surgery under general anesthesia in Taizhou Central Hospital from November 2021 to March 2022 were included. According to the score of the Pittsburgh sleep quality index (PSQI), the participating patients were divided into four groups: control group (control group), mild sleep disorder group A (group A), moderate sleep disorder group B (group B), and severe sleep disorder group C (group C), with 30 patients in each group. The changes of mean arterial pressure (MAP) and heart rate (HR) at different time points, operation time, anesthesia time, extubation time, the time when Aldrete score reached 10 points, visual analog score (VAS) serum interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-α (TNF-α) were compared among different groups. Our study demonstrated that there were no significant differences in MAP and HR among the four groups at the same time points (all P > 0.05). Significant differences in the time of extubation and Aldrete score reaching 10 points had been found among the four groups (all P < 0.001), indicating more sleep disorder induced longer extubation and recovery time. There were significant differences in VAS scores among the four groups at both different and the same time points (all P < 0.001), suggesting more sleep disorders induced more pain in the sufferers. Serum IL-6 levels were significantly higher in the three sleep disorder groups than the control group at 6 h and 24 h after the operation (all P < 0.05), while group C has the highest IL-6 levels as compared to the other group (P = 0.09 and P < 0.001, respectively). At 6 h after operation, serum levels of TNF-α in group C were significantly higher than in the control group (P = 0.044), but no significant differences were found in the other two groups (all P > 0.05). Positive correlation with preoperative PSQI score has been found with the times of extubation, the time of Aldrete score reaching 10 points, the VAS at 1 h, 6 h, and 24 h after operation, the level of serum IL-6 at 1 day before operation and 6 h and 24 h after operation, and the TNF-α at 6 h and 24 h after operation (all P < 0.001). The present study showed that the degree of preoperative sleep disorders could affect the quality of postoperative awakening and pain of patients undergoing laparoscopic gynecological surgery under general anesthesia, which might be associated with the aggravation of inflammatory reactions in the body.

Project description:ImportanceHanding over the care of a patient from one anesthesiologist to another occurs during some surgeries and might increase the risk of adverse outcomes.ObjectiveTo assess whether complete handover of intraoperative anesthesia care is associated with higher likelihood of mortality or major complications compared with no handover of care.Design, setting, and participantsA retrospective population-based cohort study (April 1, 2009-March 31, 2015 set in the Canadian province of Ontario) of adult patients aged 18 years and older undergoing major surgeries expected to last at least 2 hours and requiring a hospital stay of at least 1 night.ExposureComplete intraoperative handover of anesthesia care from one physician anesthesiologist to another compared with no handover of anesthesia care.Main outcomes and measuresThe primary outcome was a composite of all-cause death, hospital readmission, or major postoperative complications, all within 30 postoperative days. Secondary outcomes were the individual components of the primary outcome. Inverse probability of exposure weighting based on the propensity score was used to estimate adjusted exposure effects.ResultsOf the 313 066 patients in the cohort, 56% were women; the mean (SD) age was 60 (16) years; 49% of surgeries were performed in academic centers; 72% of surgeries were elective; and the median duration of surgery was 182 minutes (interquartile [IQR] range, 124-255). A total of 5941 (1.9%) patients underwent surgery with complete handover of anesthesia care. The percentage of patients undergoing surgery with a handover of anesthesiology care progressively increased each year of the study, reaching 2.9% in 2015. In the unweighted sample, the primary outcome occurred in 44% of the complete handover group compared with 29% of the no handover group. After adjustment, complete handovers were statistically significantly associated with an increased risk of the primary outcome (adjusted risk difference [aRD], 6.8% [95% CI, 4.5% to 9.1%]; P < .001), all-cause death (aRD, 1.2% [95% CI, 0.5% to 2%]; P = .002), and major complications (aRD, 5.8% [95% CI, 3.6% to 7.9%]; P < .001), but not with hospital readmission within 30 days of surgery (aRD, 1.2% [95% CI, -0.3% to 2.7%]; P = .11).Conclusions and relevanceAmong adults undergoing major surgery, complete handover of intraoperative anesthesia care compared with no handover was associated with a higher risk of adverse postoperative outcomes. These ﬁndings may support limiting complete anesthesia handovers.

Project description:Exposure of young animals to commonly used anesthetics causes neurotoxicity including impaired neurocognitive function and abnormal behavior. The potential neurocognitive and behavioral effects of anesthesia exposure in young children are thus important to understand.To examine if a single anesthesia exposure in otherwise healthy young children was associated with impaired neurocognitive development and abnormal behavior in later childhood.Sibling-matched cohort study conducted between May 2009 and April 2015 at 4 university-based US pediatric tertiary care hospitals. The study cohort included sibling pairs within 36 months in age and currently 8 to 15 years old. The exposed siblings were healthy at surgery/anesthesia. Neurocognitive and behavior outcomes were prospectively assessed with retrospectively documented anesthesia exposure data.A single exposure to general anesthesia during inguinal hernia surgery in the exposed sibling and no anesthesia exposure in the unexposed sibling, before age 36 months.The primary outcome was global cognitive function (IQ). Secondary outcomes included domain-specific neurocognitive functions and behavior. A detailed neuropsychological battery assessed IQ and domain-specific neurocognitive functions. Parents completed validated, standardized reports of behavior.Among the 105 sibling pairs, the exposed siblings (mean age, 17.3 months at surgery/anesthesia; 9.5% female) and the unexposed siblings (44% female) had IQ testing at mean ages of 10.6 and 10.9 years, respectively. All exposed children received inhaled anesthetic agents, and anesthesia duration ranged from 20 to 240 minutes, with a median duration of 80 minutes. Mean IQ scores between exposed siblings (scores: full scale?=?111; performance?=?108; verbal?=?111) and unexposed siblings (scores: full scale?=?111; performance?=?107; verbal?=?111) were not statistically significantly different. Differences in mean IQ scores between sibling pairs were: full scale?=?-0.2 (95% CI, -2.6 to 2.9); performance?=?0.5 (95% CI, -2.7 to 3.7); and verbal?=?-0.5 (95% CI, -3.2 to 2.2). No statistically significant differences in mean scores were found between sibling pairs in memory/learning, motor/processing speed, visuospatial function, attention, executive function, language, or behavior.Among healthy children with a single anesthesia exposure before age 36 months, compared with healthy siblings with no anesthesia exposure, there were no statistically significant differences in IQ scores in later childhood. Further study of repeated exposure, prolonged exposure, and vulnerable subgroups is needed.

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Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial.

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