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A comprehensive analysis of in-hospital adverse events after scopolamine administration: insights from a retrospective cohort study using a large nationwide inpatient database

BMC Anesthesiology volume 24, Article number: 438 (2024) Cite this article

Abstract

Background

Scopolamine is a widely used antiemetic in anesthetic practice, particularly for postoperative and post-discharge nausea and vomiting. Despite its frequent usage and recognized efficacy, concerns have emerged regarding the potential for increased side effects, particularly in elderly patients. Further research is needed to assess safety and determine age thresholds for adverse events. This study hypothesizes associations between perioperative scopolamine use, worse clinical outcomes, increased pneumonia, delirium, urinary retention, and readmissions.

Methods

A large, retrospective cohort study was performed using the TriNetX Analytics Network database on patients undergoing major surgical procedures between Jan 1, 2009, and March 21, 2018, to examine the impact of perioperative scopolamine use on in-hospital adverse events. Patients were divided into age groups and compared to a control group. The primary outcomes assessed were delirium, pneumonia, in-hospital death, new antipsychotic use, readmission, and new onset urinary retention within 7 days post-surgery. 1:1 propensity score matching was performed to reduce bias. Relative risk and risk differences with 95% confidence intervals were estimated.

Results

After 1:1 propensity score matching, we identified a total of 403,816 (201,908 pairs) perioperative scopolamine users and nonusers. The cohorts of 20–29, 30–39, 40–49, 50–59, 60–69, and 70 + contained 22,910 (11,455 pairs), 44,170 (22,085 pairs), 58,590 (29,295 pairs), 71,660 (35,830 pairs), 88,386 (44,193 pairs), and 118,100 (59,050 pairs) patients respectively. Across older age cohorts, after propensity score matching, perioperative scopolamine recipients had significantly increased relative risk and risk difference of delirium, pneumonia, in-hospital mortality, new antipsychotic use, readmission, and new-onset urinary retention.

Conclusions

In this cohort study, perioperative scopolamine usage was associated with a significantly increased risk of in-hospital adverse events, both within the 70 + age cohort and among the 20–29, 30–39, 40–49, 50–59, and 60–69 age cohorts after major surgery. These findings highlight the need for careful assessment of scopolamine’s risks and benefits, especially for patients aged 40 and older. Scopolamine may be most suited for post-discharge nausea and vomiting in ambulatory patients and clinicians should reassess its standard use for postoperative nausea and vomiting, favoring shorter-acting agents with fewer side effects.

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Background

Postoperative nausea and vomiting (PONV) is a common, yet complex problem affecting anesthetic care, occurring in up to 80% of high-risk patients [1,2,3,4]. Furthermore, PONV is associated with prolonged hospitalizations, increased rate of readmissions, and magnified healthcare costs [5].

Scopolamine is a common agent used for the treatment of PONV and post-discharge nausea and vomiting (PDNV) given its long duration of activity and unique transdermal dosing regimen. The agent acts as a competitive antagonist of the acetylcholine muscarinic receptor and works primarily in smooth muscle and the central nervous system to directly antagonize cholinergic synaptic transmissions [6]. The parasympathetic activity produced leads to drying of secretions, increased cardiac output, and reduced nausea and vomiting [7]. According to consensus guidelines, the risk of experiencing delayed nausea and vomiting significantly diminishes after the age of 50, making it a less prominent concern in older populations [8]. Despite scopolamine’s frequent usage and recognized efficacy, concerns have emerged regarding the potential for increased side effects, particularly in elderly patients. This population faces an elevated risk of delirium and potential side effects due to scopolamine’s anticholinergic properties [9]. The adverse effects of scopolamine are well documented, with patients receiving transdermal scopolamine commonly experiencing effects such as urinary retention, dry mouth, mydriasis, visual disturbances, and amblyopia [10,11,12,13,14]. Furthermore, the use of transdermal scopolamine may result in significant elevations in heart rate when compared to placebo [15]. Surprisingly, while numerous case reports have highlighted these concerns, no comprehensive study has quantified the frequency and severity of these side effects in the context of scopolamine administration in elderly patients. This critical gap in our understanding warrants further investigation on the safety and appropriateness of scopolamine use in this particular patient population. We therefore hypothesized that perioperative scopolamine use in older adults would be associated with worse clinical outcomes, mainly increased risk of pneumonia, delirium, urinary retention, and increased rate of readmissions.

Methods

This retrospective cohort study was performed using the TriNetX platform (TriNetX Analytics Network, Cambridge, MA) to investigate attributes related to the association of perioperative scopolamine use with in-hospital adverse events. TriNetX provides access to de-identified clinical data from electronic health records of millions of patients and has been shown to be useful in retrospective cohort studies investigating clinical outcomes. The extensive database includes patient demographics, admission status, procedural notes, medication administrations, laboratory values, diagnosis codes, genomic information, and discharge status. The TriNetX platform is compliant with the Health Insurance Portability & Accountability Act and General Data Protection Regulation.

The initial query included 40 million patients to identify patients who had a major, inpatient or outpatient, surgical procedure (gastrointestinal, genitourinary, orthopedic, neurological, thoracic, and vascular) and received perioperative scopolamine within 24 h of surgery. Patients who underwent cardiac surgery were excluded because of the unique perioperative management and pharmacological requirements specific to cardiac surgeries. The patients were selected based on diagnostic coding for surgical procedures and scopolamine administration that took place between Jan 1, 2009, and March 21, 2018. Major surgical procedures were defined according to the Agency for Healthcare Research and Quality classification [16, 17]. Patients who were in the intensive care unit prior to surgery were excluded. This initial step produced N = 14,298,446 patients which were subsequently divided into six age cohorts: 20–29, 30–39, 40–49, 50–59, 60–69, and 70+. Using the same search strategy, patients who did not receive scopolamine were included as a control group. Palliative care patients and patients with prior antipsychotic or scopolamine use within three months of the surgical procedure were excluded. The consort diagram in Fig. 1 illustrates the steps used to obtain the final study cohorts.

Fig. 1
figure 1

Inclusion / Exclusion flow diagram

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Patient demographics (age, sex, race, and ethnicity), comorbidities (as defined by Charlson Comorbidity Index) [18], and exposure to medications were assessed. The outcomes of interest were obtained up to 7 days after surgery and included delirium, pneumonia, in-hospital death, new antipsychotic use, readmission, and new onset urinary retention.

To minimize confounding, balancing of the groups was performed using 1:1 propensity score matching for each study cohort (70+, 60–69, 50–59, 40–49, 30–39, and 20–29). 1:1 matching was performed based on the propensity scores generated by using greedy nearest neighbor algorithms utilizing a caliper width of 0.1 pooled standard deviations (SD0). Balance on covariates was assessed using standardized mean difference, and absolute values > 0.1 were considered positive for residual imbalance. A two-sided alpha of less than 0.05 was defined as a priori for statistical significance. Risk ratios with 95% confidence intervals were calculated for all analyses. Variable selection for inclusion into the model were: sex, race, ethnicity, BMI, surgery type (gastrointestinal, genitourinary, orthopedic, neurological, thoracic, and vascular), prior history of coagulation disorders, benign prostatic hyperplasia, prior history of delirium, prior history of opioid use disorder, and the individual components of the comorbidity burden (as defined by Charlson Comorbidity Index: history of myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes, hemiplegia, chronic kidney disease, tumor burden, and acquired immunodeficiency syndrome (AIDS) status). We calculated relative risk (RR), risk differences (RDs), and 95% confidence intervals (CIs) to assess the associations between perioperative scopolamine use and delirium, pneumonia, in-hospital death, new antipsychotic use (POD1-7), readmission, and new onset urinary retention.

Results

We identified a total of 201,908 patients aged 20 and above who underwent a major surgical procedure and received perioperative scopolamine within 24 h of surgery between January 1, 2009, and March 21, 2018. In the same timeframe, we identified 14,100,875 patients aged 20 and above who underwent a major surgical procedure and did not receive perioperative scopolamine. After 1:1 propensity score matching each age group cohort, we identified a total of 403,816 (201,908 pairs) perioperative scopolamine users and nonusers. The cohorts of 20–29, 30–39, 40–49, 50–59, 60–69, and 70 + contained 22,910 (11,455 pairs), 44,170 (22,085 pairs), 58,590 (29,295 pairs), 71,660 (35,830 pairs), 88,386 (44,193 pairs), and 118,100 (59,050 pairs) patients respectively. The baseline characteristics: sex, race, ethnicity, surgery type, and comorbidity burden pre and post propensity score matching are shown in Table 1. The treatment cohorts were well balanced, with standardized mean differences less than 0.1.

Table 1 Pre- and post-propensity score matching characteristics, Age Cohort > 70
Full size table

The outcome data for the study are presented for each of the 5 age categories in Tables 2, 3, 4, 5, 6 and 7. Patients who had perioperative scopolamine administration had significantly increased RR for in-hospital mortality (Table 2), delirium (Table 3), pneumonia (Table 4), new antipsychotic use (Table 5), readmission (Table 6), and new-onset urinary retention (Table 7) (Fig. 2).

Table 2 Association between perioperative scopolamine administration and postoperative mortality
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Table 3 Association between perioperative scopolamine administration and postoperative delirium
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Table 4 Association between perioperative scopolamine administration and postoperative pneumonia
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Table 5 Association between perioperative scopolamine administration and postoperative new antipsychotic use
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Table 6 Association between perioperative scopolamine administration and postoperative readmission
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Table 7 Association between perioperative scopolamine administration and postoperative urinary retention
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Fig. 2
figure 2

Kaplan Meier Survival Curve, Age 70 + at 30 days

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Discussion

Within the scope of this retrospective cohort study, we found a significant association between perioperative scopolamine administration and an increased risk of delirium and mortality. Notably, scopolamine administration was linked to a heightened mortality risk across all age groups, with the magnitude of this risk escalating with each advancing decade—tripling in individuals aged 60–69 and quadrupling in those aged 70 and older. In patients over 70, the mortality rate reached a concerning 7% among those administered scopolamine, compared to 1.7% in the matched cohort who did not receive the drug. These findings remained robust even after adjusting for potential confounders, including the Charlson Comorbidity Index, body mass index, smoking status, and additional risk factors for delirium [19]. While scopolamine is commonly used in the perioperative setting to prevent postoperative nausea and vomiting, these results indicate a potential trade-off in terms of patient safety, particularly among the older age cohorts.

Scopolamine may elevate the risk of mortality by directly inducing neuroinflammation and disrupting the regulatory mechanisms that control it. Recent studies in animal models demonstrate that scopolamine provokes inflammation in the brain and is used experimentally to induce learning and memory deficits, thereby mimicking Alzheimer’s disease in mice [20,21,22]. Acetylcholine, a neurotransmitter, is crucial in modulating the brain’s inflammatory response by inhibiting cytokine release from microglia [23]. Scopolamine’s anticholinergic properties may compromise this inhibitory effect, leading to unchecked neuroinflammation. This unchecked release of proinflammatory cytokines can further activate microglia, creating a feedback loop that perpetuates neuroinflammation, potentially causing sustained brain damage even months after exposure [24].

This persistent and uncontrolled neuroinflammation results in neurotoxicity, severe and prolonged delirium, persistent dementia, and, ultimately, death. Scopolamine increases the risk of delirium, which is strongly associated with higher mortality. A meta-analysis demonstrated that hospitalized patients with delirium faced more than a threefold increase in the risk of death compared to those without delirium [25]. In the critical care setting, two meta-analyses by Sahle et al. and Salluh et al. reported more than a twofold increase in mortality risk, along with prolonged mechanical ventilation time, longer hospital stays, and a heightened risk of cognitive impairment after discharge [26, 27].

Supporting this hypothesis, our study found an increased risk of delirium in patients over the age of 60, despite not having significantly higher use of deliriogenic medications, such as benzodiazepines (Supplemental Table S1). These results align with the American Geriatrics Society’s strong recommendation to avoid the use of anticholinergic agents, such as scopolamine, in elderly patients [28]. This also corroborates the findings of a retrospective study by Herrmann et al., which identified a strong association between the administration of anticholinergic medications and postoperative delirium in older patients undergoing elective surgery [29].

Although the absolute risk of delirium was over 1% only in the 70 + age group, this is likely an underestimation. TriNetX relies on the logging of CPT codes, and cases of mild to moderate delirium that respond to treatment are often not recorded. In contrast, a meta-analysis by Sadeghirad et al. found that 18% of adults undergoing non-cardiac surgery met the criteria for delirium [34]. The studies included in this meta-analysis employed well-validated and highly specific tools for assessing delirium, such as the Confusion Assessment Method (CAM) and the Delirium Observation Screening Scale (DOSS), which primarily screen for inattention, confusion, and sedation — symptoms that are commonly observed after surgery [30, 31].

Additional indicators of delirium were also observed. Postoperative pneumonia, a marker of sedation (a key feature of delirium), increased in patients over 50, as postoperative pneumonia is often caused by micro-aspiration of gram-negative bacteria [32]. There was also an increase in new antipsychotic use across all age groups, likely reflecting a rise in symptoms of agitation. However, since scopolamine is an effective antiemetic for delayed nausea and vomiting, antipsychotic use for PONV should have decreased in the group receiving transdermal scopolamine. Instead, we found that patients who received scopolamine were over 70% more likely to require antipsychotic medication in the days following surgery, suggesting their use was driven by other factors, such as agitation.

Scopolamine use was also associated with an increased risk of urinary retention across all age groups. This finding is consistent with recent studies, such as by Courtepatte et al., which reported a 75% increase in the incidence of postoperative urinary retention (POUR) following uro-gynecological surgeries associated with scopolamine [33]. Our findings add to a growing body of evidence that challenges the meta-analysis of retrospective studies by Lanpher et al., which found no statistically significant increase in POUR among patients receiving scopolamine [34]. However, the absolute risk of urinary retention exceeded 1% only in patients over the age of 70. This is likely an underestimation, as previous studies have reported the incidence of POUR to range from 4 to 70%, depending on the type of surgery [35]. Additionally, readmission for any reason was higher in all age groups, which may reflect urinary retention as well as other serious medical complications, such as delirium, excessive sedation, or postoperative pneumonia. While the absolute risk of readmission was low, it represents a significant cost burden on the healthcare system.

These findings are particularly relevant because healthcare providers may not be fully aware of the risks associated with scopolamine use in elderly patients. According to our data, the use of scopolamine appears to increase with age, with the highest number of patients receiving the drug being in the 70 + age category. This may reflect the higher frequency of surgeries among older adults; according to the 2018 National Health Interview Survey (NHIS), 19% of Americans over the age of 65 had surgery in the previous year [36]. These observations underscore the notion that scopolamine use carries inherent risks and should be judiciously considered, with a clear evaluation of the benefit-to-risk ratio. In cases of postoperative nausea and vomiting, alternative antiemetic options with more favorable side effect profiles may be more prudent choices over scopolamine. It is conceivable that scopolamine’s utility may be best suited for younger patients and individuals with a documented history of PDNV, where its benefits may outweigh the associated risks.

Limitations

As with any retrospective cohort study relying on administrative data, our findings may be limited by the confines of the database and skewed by diagnostic coding errors. Diagnostic coding may overestimate or underestimate the incidence of adverse events. Additionally, the outcomes may have been influenced by unaccounted-for confounding factors that were not part of our analyses. Finally, after 1:1 propensity score matching, certain cohorts within the younger age group had limited patient numbers, which presents difficulties in extending the generalizability of our results to larger populations. Along with the intrinsic limitations of 1:1 propensity score matching, the lack of dosage information and time of administration of medications are not available through the TriNetX database, which may affect the generation of cohorts. The patients within the TriNetX network may not be fully representative of the entire United States population, including healthy populations and those who may not have had medical encounters with health care systems.

Conclusion

In this retrospective cohort study, perioperative scopolamine usage was associated with a significantly increased risk of in-hospital mortality, delirium, pneumonia, new antipsychotic utilization, readmission, and urinary retention both within all age cohorts after major surgery, but especially in the > 60 age cohort. These findings underscore the importance of carefully evaluating the risks and benefits of scopolamine administration in perioperative settings, particularly within these age groups. Scopolamine is most suited for post-discharge nausea and vomiting in ambulatory patients given its 4-hour onset time, and its 72-hour duration. Clinicians should reconsider scopolamine’s routine use in treating postoperative nausea and vomiting.

Data availability

The datasets generated and/or analyzed during the current study are available from TriNetX Analytics Network (Cambridge, MA), but restrictions apply to the availability of these data. Data is however available from the corresponding author on reasonable request and with permission of TriNetX Analytics Network.

Abbreviations

PDNV:

Post-discharge nausea and vomiting

PONV:

Postoperative nausea and vomiting

RCT:

Randomized controlled trial

AIDS:

Acquired immunodeficiency syndrome

RR:

Relative risk

RD:

Risk difference

CI:

Confidence interval

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Authors and Affiliations

  1. Department of Anesthesiology and Perioperative Medicine, Thomas Jefferson University, 111 S 11th St Gibbon Building, Philadelphia, PA, 8330, 19107, USA

    George Sun, Marc C. Torjman & Kevin J. Min

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Contributions

GS and KM conceptualized and designed the study. GS collected and organized the data, performed the initial analysis, and drafted the manuscript. KM reviewed and revised the manuscript for important intellectual content and reviewed the initial analyses. The authors read and approved the final manuscript.

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Correspondence to Kevin J. Min.

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This retrospective study is exempt from informed consent because no protected health information is provided. We received a waiver from Thomas Jefferson University Institutional Review Board (IRB) to perform this study. The data reviewed is a secondary analysis of existing data, does not involve intervention or interaction with human subjects, and is de-identified per the de-identification standard defined in Section § 164.514(a) of the HIPAA Privacy Rule. The process by which the data is de-identified is attested to through a formal determination by a qualified expert as defined in Section § 164.514(b)(1) of the HIPAA Privacy Rule. This formal determination by a qualified expert was refreshed in December 2020.

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Sun, G., Torjman, M.C. & Min, K.J. A comprehensive analysis of in-hospital adverse events after scopolamine administration: insights from a retrospective cohort study using a large nationwide inpatient database. BMC Anesthesiol 24, 438 (2024). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12871-024-02824-y

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