Safety of Midazolam for HIV Patients Undergoing Colonoscopy
Safety of Midazolam for HIV Patients Undergoing Colonoscopy
HIV-positive patients who were 18 years of age or older and who underwent out-patient colonoscopy at Massachusetts General Hospital between 1 January 2007 and 30 June 2010 were identified through the Research Patient Data Registry (RPDR), a clinical database for the Partners Health-Care System. Inclusion criteria were: (1) completion of colonoscopy; (2) receipt of ART for a minimum of 4 weeks at the time of the colonoscopy; (3) receipt of midazolam- or diazepam-based sedation.
Gastrointestinal (GI) endoscopy procedure flow sheets were reviewed for each patient. Flow sheets included scores assigned by the providers for selected physiological parameters. Demographic data, past medical history, and medication data were documented for each patient and confirmed via review of the electronic medical record.
Primary outcomes were sedation duration, nadir SBP, nadir oxygen saturation, rate of abnormal cardiac rhythm, and change in level of consciousness. Level of consciousness was assessed using an institutional scale on which a score of 2 represents awake and oriented, 1 represents arousable or disoriented, and 0 represents unresponsive. Secondary outcomes included change from baseline in respiratory rate, heart rate, airway status, quality of respirations, skin perfusion, SBP, pain score, procedure time, and total monitoring time required as documented in the post-procedure report.
Univariate analyses of associations between exposures and outcomes were performed using Student's t-test for continuous variables and the Wald χ test or Fisher's exact test for categorical variables. Multivariate analyses were completed using logistic regression models. Covariates included in the analyses were concomitant cytochrome (CYP) 3A4 inhibitors, chronic opioid use, chronic benzodiazepine use, liver disease, age and gender. In a separate analysis, outcomes were analysed by four treatment groups: PI/midazolam; PI/diazepam; non-PI/midazolam; non-PI/diazepam. A P-value < 0.05 was considered to be statistically significant.
Methods
Study Population
HIV-positive patients who were 18 years of age or older and who underwent out-patient colonoscopy at Massachusetts General Hospital between 1 January 2007 and 30 June 2010 were identified through the Research Patient Data Registry (RPDR), a clinical database for the Partners Health-Care System. Inclusion criteria were: (1) completion of colonoscopy; (2) receipt of ART for a minimum of 4 weeks at the time of the colonoscopy; (3) receipt of midazolam- or diazepam-based sedation.
Data Collection
Gastrointestinal (GI) endoscopy procedure flow sheets were reviewed for each patient. Flow sheets included scores assigned by the providers for selected physiological parameters. Demographic data, past medical history, and medication data were documented for each patient and confirmed via review of the electronic medical record.
Outcomes
Primary outcomes were sedation duration, nadir SBP, nadir oxygen saturation, rate of abnormal cardiac rhythm, and change in level of consciousness. Level of consciousness was assessed using an institutional scale on which a score of 2 represents awake and oriented, 1 represents arousable or disoriented, and 0 represents unresponsive. Secondary outcomes included change from baseline in respiratory rate, heart rate, airway status, quality of respirations, skin perfusion, SBP, pain score, procedure time, and total monitoring time required as documented in the post-procedure report.
Statistical Analysis
Univariate analyses of associations between exposures and outcomes were performed using Student's t-test for continuous variables and the Wald χ test or Fisher's exact test for categorical variables. Multivariate analyses were completed using logistic regression models. Covariates included in the analyses were concomitant cytochrome (CYP) 3A4 inhibitors, chronic opioid use, chronic benzodiazepine use, liver disease, age and gender. In a separate analysis, outcomes were analysed by four treatment groups: PI/midazolam; PI/diazepam; non-PI/midazolam; non-PI/diazepam. A P-value < 0.05 was considered to be statistically significant.
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