Abstract
Introduction
Esophagogastroduodenoscopy (EGD) is a diagnostic and therapeutic procedure increasingly performed worldwide that can be done with or without sedation.
Aim
The aim of the study was to evaluate how common EGD intolerance without sedation is among a group of patients in a Western country.
Methods
A cross-sectional study at a Portuguese hospital reviewed EGD procedures without sedation from January 2021 to March 2024. Reports indicated patient tolerance (well tolerated or intolerant). Only patients aged 18 or older were included. When patients had multiple EGDs without sedation within the analysis period, only the first procedure was analysed. Data collected from endoscopy reports included gender, age, EGD setting, and a history of previous upper gastrointestinal tract surgery.
Results
This study involved 849 patients who underwent unsedated EGD, with 452 males and 397 females. Of these, 258 patients (30.4%) did not tolerate the procedure. Younger patients (under 50 years old) exhibited significantly higher intolerance than older patients, with adjusted odds ratio (AOR) of 3.14 (95% CI 2.06–4.79, p < 0.001). Additionally, females showed greater intolerance compared to males, with an AOR of 1.41 (95% CI 1.04–1.90, p = 0.025).
Conclusion
Approximately one-third of patients are unable to tolerate EGD without sedation. Younger age (<50 years) and female gender were independent predictors of intolerance to unsedated EGD. This high prevalence highlights the importance of providing sedation during EGD to decrease patient discomfort, avoid the need for a repeat EGD due to an inconclusive unsedated first attempt, improve diagnostic accuracy by meeting performance standards, and reduce the risk of missing precancerous conditions or lesions.
Keywords: Esophagogastroduodenoscopy, Sedation, Intolerance, Prevalence
Plain Language Summary
Esophagogastoduodenoscopy (EGD) is increasingly used worldwide, providing direct visualization of the upper gastrointestinal tract. It can be performed with or without sedation. Without sedation, it may cause discomfort and is not tolerated by all patients. The exact rate of intolerance to unsedated EGD has not been established in the literature, especially in Western populations, which is the focus of this study. We analysed consecutive reports of unsedated diagnostic EGD procedures performed at a hospital in Portugal from 2021 to 2024, classifying patient tolerance as either well tolerated or intolerant. Our results show that nearly one-third of patients are intolerant of unsedated EGD, with higher intolerance observed in females and younger individuals. This high prevalence highlights the importance of sedation during diagnostic EGD to enhance patient comfort and ensure the procedures are conclusive and meet quality standards in endoscopy.
Resumo
Introdução
A endoscopia digestiva alta (EDA) é um procedimento diagnóstico e terapêutico cada vez mais utilizado em todo o mundo que pode ser realizado com ou sem sedação.
Objetivo
Avaliar a prevalência de intolerância à EDA sem sedação numa amostra de doentes num país ocidental.
Métodos
Estudo transversal conduzido num hospital português que analisou relatórios de EDA, realizadas sem sedação, entre janeiro de 2021 e março de 2024. Os relatórios mencionavam a tolerância de cada doente ao procedimento (tolerante ou intolerante). Apenas foram incluídos doentes com mais de 18 anos. Quando os doentes foram submetidos a mais de uma EDA durante este período, apenas a primeira foi considerada. Os dados recolhidos foram género, idade, contexto e existência prévia de cirurgia gastrointestinal do trato superior.
Resultados
Este estudo incluiu 849 doentes que realizaram EDA sem sedação (452 homens e 397 mulheres). No total, 258 doentes (30,4%) foram intolerantes à EDA sem sedação. Doentes mais jovens (abaixo dos 50 anos de idade) mostraram mais intolerância à EDA do que doentes mais velhos, com odds ratio ajustado (AOR) de 3.14 (IC 95% 2.06–4.79, p < 0.001). O género feminino também mostrou estar associado a maior intolerância à EDA do que o género masculino, com AOR de 1.41 (IC 95% 1.04–1.90, p = 0.025).
Conclusão
Aproximadamente um terço dos doentes pode ser incapaz de tolerar EDA diagnóstica sem sedação. Adultos jovens e o género feminino são fatores associados à intolerância de forma estatisticamente significativa. A elevada prevalência de intolerantes à EDA sem sedação destaca a importância da sedação para realizar este procedimento endoscópico, de forma a diminuir o desconforto dos doentes, evitar repetição de EDAs devido a uma primeira inconclusiva sem sedação, melhorar a acuidade diagnóstica da endoscopia ao cumprir os critérios de qualidade preconizados e assim reduzir risco de não deteção de condições ou lesões pré-malignas.
Palavras Chave: Endoscopia Digestiva Alta, Sedação, Intolerância, Prevalência
Introduction
Esophagogastroduodenoscopy (EGD), also known as upper digestive endoscopy or gastroscopy, is an invasive procedure increasingly used worldwide that allows the direct visualization of the upper gastrointestinal (UGI) tract up to the second part of the duodenum. This method can be carried out with or without sedation and is suitable for both diagnostic and therapeutic interventions [1–3].
According to the European Society of Gastrointestinal Endoscopy (ESGE) performance measures for EGD, a diagnostic EGD should last at least 7 minutes from intubation to extubation, as this is the minimum time needed to thoroughly inspect the entire mucosa of the UGI tract [4]. An EGD lasting at least 7 minutes is twice as likely to detect high-risk gastric changes and three times more likely to find gastric cancer, improving procedure quality. In cases like Barrett’s oesophagus, spending about 1 minute per centimetre of affected tissue maximizes the chance of detecting dysplasia if it is present [4, 5].
Sedation or general anaesthesia is usually required for therapeutic purposes, while unsedated EGD remains common for diagnosis and surveillance. However, the tolerance to EGD greatly affects the success of the procedure, even when it is performed for diagnostic or surveillance purposes. An intolerant patient may hinder a complete endoscopy, restrict proper mucosal evaluation, and compromise the detection of precancerous lesions and conditions. This intolerance can also prevent necessary targeted or mapping biopsies. Additionally, intolerant patients face a higher risk of complications like lacerations, perforations, and cardiopulmonary issues [4, 6–8].
Furthermore, EGD without sedation causes discomfort and can trigger pain, nausea, coughing, and vomiting, especially in intolerant patients. Many patients delay the procedure because of fear and anxiety, and some must repeat EGD after an inconclusive initial gastroscopy due to intolerance [9–11].
Many EGDs worldwide, namely, in Portugal, are still performed without sedation due to financial constraints or the unavailability of slots with anaesthesiologists in public healthcare hospitals. The prevalence of patient intolerance to this procedure has been rarely discussed, especially in the West. This study aimed to assess the prevalence of intolerance to EGD without sedation among a sample of patients in a Western country.
Materials and Methods
A cross-sectional study was conducted at Pêro da Covilhã Hospital in Portugal. From January 2021 to March 2024, reports of diagnostic EGD procedures without sedation, performed by a specialized advanced endoscopy gastroenterologist at the Endoscopy Unit, were consecutively reviewed. The gastroenterologist consistently recorded when a patient was intolerant to EGD in the report. The endoscopist defined intolerance using objective criteria observed during the procedure. These included ongoing vomiting, coughing, significant discomfort, pain, agitation, uncooperative behaviour, and/or hemodynamic instability caused by EGD, which prevented a complete and conclusive EGD and hindered the recommended inspection time.
Only patients aged 18 or older were included. For patients who had more than one EGD during this period, only the first procedure was analysed.
All data were retrospectively collected from endoscopy reports obtained from the endoscopy database. Gender, age, context of EGD (scheduled or urgent), and previous UGI tract surgery were considered. The tolerance level was categorized as either well tolerated or intolerant.
Continuous variables were expressed as means with standard deviations, and categorical variables as frequencies and percentages. To compare the categorical variables between the analysed groups, a chi-squared test was applied. Unadjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated from cross-tabulations. Binary logistic regression models (forward stepwise method) were used to estimate adjusted ORs (AORs) and the related 95% CIs. All variables (sex, age, context, and previous UGI tract surgery) were included in multivariate analysis. p value ≤0.05 was considered statistically significant. Model fit statistics, such as the likelihood ratio test and the Hosmer-Lemeshow test, were assessed. All descriptive and inferential statistical analyses were performed using the Statistical Package for Social Sciences (SPSS) software for Windows (version 29). This study adhered to the principles of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) [12].
Results
This study included 849 patients who underwent EGD without sedation. All procedures were conducted under a local anaesthetic spray containing lidocaine and utilizing standard high-resolution video gastroscopes from Fujifilm or Olympus. Among these patients, 452 (53.2%) were male and 397 (46.8%) were female. The mean age was 67.6 (±14.3) years for males, 68.2 (±16.6) years for females, and 67.9 (±15.4) years overall. The age distribution was as follows: 103 (12.1%) patients were under 50 years, and 746 (87.9%) were 50 years or older.
The most common indications for EGD were anaemia, dyspepsia, and surveillance. Out of the total, 698 patients (82.2%) underwent scheduled EGD, while 151 patients (17.8%) had urgent EGDs. Only 59 patients (6.9%) had previously undergone UGI tract surgery.
A total of 258 patients (30.4%) were intolerant to unsedated EGD. Among these intolerant patients, 41 (15.9%) did not allow progression to the duodenum or jejunum, while 217 (84.1%) permitted it. The comparison between tolerant and intolerant patients, along with univariate and multivariate analyses, is presented in Table 1. Patients aged 50 or older showed a higher tolerance to EGD compared to younger patients (OR 3.21, 95% CI 2.11–4.88, p < 0.001). After adjustment, the OR suggests that being under 50 remained an independent predictor of intolerance (AOR 3.14, 95% CI 2.06–4.79, p < 0.001). Additionally, female gender was associated with higher odds of intolerance (OR 1.47, 95% CI 1.10–1.98, p = 0.009). Following adjustment, being female remained a predictor of intolerance to EGD (AOR 1.41, 95% CI 1.04–1.90, p = 0.025). The setting of the EGD, whether scheduled or urgent, and a history of previous UGI tract surgery showed no link to intolerance of unsedated EGD (OR 0.76 [95% CI 0.51–1.13, p = 0.179] and OR 1.29 [95% CI 0.74–2.24, p = 0.368], respectively). After adjustment, context (urgent/scheduled) and previous UGI tract surgery remained unrelated to intolerance (AOR 0.78 [95% CI 0.52–1.18, p = 0.240] and AOR 1.42 [95% CI 0.81–2.50, p = 0.226], respectively). The model fit statistics were evaluated; the likelihood ratio test yielded a p value of less than 0.001, signifying that the model is statistically significant. Additionally, the Hosmer-Lemeshow test indicated a p value of 0.086, suggesting an adequate fit of the model.
Table 1.
Sample characterization, along with univariate and multivariate analyses
| | Patients intolerant to unsedated EGD, n =258 | Patients tolerant to unsedated EGD, n =591 | Univariate analysis | Multivariate analysis | ||||
|---|---|---|---|---|---|---|---|---|
| OR | 95% CI | p value | OR | 95% CI | p value | |||
| Age, n (%) | ||||||||
| <50 years old | 56 (21.7) | 47 (8.0) | 3.21 | 2.11−4.88 | <0.001 | 3.14 | 2.06−4.79 | <0.001 |
| ≥50 years old | 202 (78.3) | 544 (92.0) | 1 | | | 1 | | |
| Gender, n (%) | ||||||||
| Female | 138 (53.5) | 259 (43.8) | 1.47 | 1.10−1.98 | 0.009 | 1.41 | 1.04−1.90 | 0.025 |
| Male | 120 (46.5) | 332 (56.2) | 1 | | | 1 | | |
| Context, n (%) | ||||||||
| Scheduled | 219 (84.9) | 479 (81.0) | 0.76 | 0.51−1.13 | 0.179 | 0.78 | 0.52−1.18 | 0.240 |
| Urgent | 39 (15.1) | 112 (19.0) | 1 | | | 1 | | |
| Previous UGI tract surgery, n (%) | ||||||||
| No | 237 (91.9) | 553 (93.6) | 1.29 | 0.74−2.24 | 0.368 | 1.42 | 0.81−2.50 | 0.226 |
| Yes | 21 (8.1) | 38 (6.4) | 1 | | | 1 | | |
CI, confidence interval; EGD, esophagogastroduodenoscopy; OR, odds ratio; UGI, upper gastrointestinal.
Likelihood ratio test p < 0.001; Hosmer-Lemeshow test p = 0.086.
Discussion
To our knowledge, this is among the largest studies conducted on the prevalence of patients intolerant to unsedated EGD. The findings indicated that 30% of patients could not tolerate the procedure without sedation, with higher intolerance rates observed among younger individuals and females.
Naturally, this study had some limitations. It was unicentric and conducted at a hospital in inland Portugal with an older, resilient population. Therefore, younger patients are underrepresented, which could lead to an underestimation of the prevalence of subjects intolerant to EGD. All procedures were performed and documented by a single endoscopist, which limits generalizability. Data were collected retrospectively, so some variables could not be accounted for. No standardized or validated scale was employed to assess patient tolerance to unsedated EGD. However, the operator’s criteria outlined in the Methods section were consistently applied. Despite these limitations, this study included over 800 patients consecutively, which helps ensure statistical accuracy.
Several factors are known to influence patients’ tolerance to unsedated EGD, including age, gender, pre-procedure anxiety due to fear of discomfort from the emetic reflex, pain, complications, examination outcomes, discomfort during the procedure, endoscope diameters, and issues of safety and privacy [13–17]. A previous study in Portugal examined whether deep sedation influences EGD performance metrics set by ESGE. The study involved 90 patients undergoing unsedated EGD, with 19 patients (21.1%) unable to tolerate the procedure. It was found that patients who were intolerant were more often female (63.2% vs. 36.8%, p = 0.509) and younger than those who tolerated EGD, with an average age of 52.2 years compared to 61.2 years (p = 0.089) [11].
Our study found that young patients (under 50 years old) were significantly more likely to experience intolerance to unsedated EGD, whereas older age was a significant protective factor. In the multivariate analysis, younger subjects had 3.14 times higher odds of exhibiting intolerance to the procedure compared with older patients. This aligns with some literature reports indicating that EGD without sedation tends to be more successful in elderly patients, as ageing is associated with decreased pharyngeal sensitivity and reflexes [13–15]. Both univariate and multivariate analyses showed that female gender is associated with higher odds of intolerance, with female patients having a 41% greater chance of intolerance compared to male patients.
Sedation practices for endoscopy vary across guidelines and depend on factors such as a country’s level of development, regional influences, reimbursement policies, and cultural norms [18–20]. In many Asian countries, the Middle East, and some European nations, unsedated EGD is routine [21]. A Bangladeshi study with 1,096 patients found only 14.03% of males and 18.02% of females could not tolerate unsedated EGD, suggesting sedation for anxious or uncooperative patients [22]. Similar results were observed in Nigeria and India, where most participants tolerated and would repeat the procedure without sedation [23, 24]. A Chinese multicentre study showed that many patients preferred unsedated EGD due to concerns about the cognitive effects, safety, and costs of sedation [25, 26]. The primary risks of sedated EGD are cardiopulmonary events; however, recent research indicates that deep sedation with propofol is safe and effective [27, 28]. Tolerance to unsedated EGD can differ between Eastern and Western populations. This variation is largely influenced by cultural and social factors rather than purely biological reasons. In many Eastern cultures, pain is seen as an integral part of the human experience and is often valued as a sign of resilience or spiritual growth. This outlook may account for their higher tolerance levels for unsedated EGD, in contrast to our sample from a Western country, where comfort is prioritized and there is a tendency to avoid physical discomfort [29].
Despite differences in sociocultural and economic factors across countries, experts reached a broad consensus: sedation removes patients’ intolerance, enhances the quality of examination, and is linked to higher diagnostic accuracy [11, 30]. Recent evidence indicates that patients undergoing sedated EGD have sufficient inspection time (at least 7 minutes from intubation to extubation), compared to those undergoing unsedated EGD [3, 4].
Current guidelines on sedation practices indicate that minimal to moderate sedation (commonly with benzodiazepines and/or opioids) or deep sedation (using propofol) can be safely performed under the guidance of an endoscopist with a properly trained team. The involvement of an anaesthesiologist should be limited to selected patients (such as those with American Society of Anesthesiologists [ASA] >II, obesity, or difficult airway) or during complex or therapeutic procedures [18, 20, 31]. However, recent studies indicate that a significant proportion of endoscopists (around 40%) have not received formal training in sedation administration, and most lack confidence in managing some less common serious adverse effects of deep sedation [20]. Therefore, we consider it essential that an anaesthesiologist, who inherently possesses experience in managing sedation drugs, vasopressors, and airway or cardiovascular complications that may occur during invasive procedures such as an EGD, is present to oversee the sedation process.
Sedation in EGD can lead to extra costs from a financial standpoint, involving personnel, hospital supplies, and medications [18, 32]. However, if a patient undergoes an unsedated EGD and cannot tolerate it, the procedure is usually inconclusive, causing delays in important diagnoses and raising the risk of missing malignant lesions [6, 33]. In such cases, a sedated gastroscopy is usually advised afterwards, which adds inconvenience and additional costs for a second procedure [11]. Consequently, broader adoption of sedation (balanced against cost and complexity) should be considered when prioritizing patient comfort, accurate diagnosis, and efficiency. Although recent international guidelines emphasize tailored sedation based on patient and procedure factors, in countries like Portugal, the decision in public primary health care also depends on the patient’s financial capacity, as the National Health System does not cover sedation. While this restraint persists, alternatives like ultra-thin transnasal endoscopy can offer better patient tolerance without sedation and a good safety profile when compared to conventional EGD [34, 35].
In conclusion, this study offers strong real-world evidence of a high rate of intolerance to unsedated diagnostic EGD in a Western public hospital setting, especially among young adults and females. Nearly one-third of patients are unable to tolerate diagnostic EGD without sedation. This high prevalence underscores the need for sedation during diagnostic EGD to prevent patient discomfort, enhance diagnostic accuracy by meeting performance standards, and reduce the risk of missing precancerous conditions or lesions.
Statement of Ethics
This study, number 106/2024, received approval from the Ethics Committee of Pêro da Covilhã Hospital, Health Local Unit of Cova da Beira in Covilhã, Portugal, in 2024.
Conflict of Interest Statement
The authors declare that they have no conflicts of interest.
Funding Sources
This research received no sponsorship or funding from any organization.
Author Contributions
Ana Beatriz Pires: conception, search, data extraction, statistical analysis, and manuscript drafting. Pedro Marcos: supervision, conception, guidance, and review.
Funding Statement
This research received no sponsorship or funding from any organization.
Data Availability Statement
All pertinent data for this study are included within the article and can be provided promptly upon request.
Supplementary Material.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All pertinent data for this study are included within the article and can be provided promptly upon request.