An interventional study of BIS monitor and Ramsay scale in Colonoscopy, sponsored by Hospital Galdakao-Usansolo. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Hospital Galdakao-Usansolo · Not applicable, Interventional, and Diagnostic
The primary aim of the study is to determine the rate sedation-induced adverse events, comparing BIS-guided sedation with clinical observation. Secondary outcomes were to examine patient characteristics who developed adverse events, propofol and remifentanil dosage and patient satisfaction analyzing different time points undergoing elective colonoscopy.
Randomized double-blind clinical trial in patients undergoing scheduled colonoscopies in endoscopy rooms of the Galdakao-Usánsolo Hospital (Bizkaia, Spain) and Mendaro Hospital (Gipuzkoa, Spain). The investigators will compare the rate of cardiorrespiratory adverse events as well as the anesthetic drugs dosage, need for rescue medication and patient satisfaction among the experimental group in which sedation is guided by BIS and the control group in which the anesthesiologist is blind to the result of the BIS. The investigators hypothesized that BIS monitoring would be associated with better outcomes than clinical observation.
The BIS is the parameter of anesthetic depth monitoring most used today. Its use was approved by the Food and Drug Administration (FDA) in 1996 as an aid to control the effects of certain anesthetic agents. It is validated in the operating room (Recommendation grade A), but not outside it due to lack of conclusive studies.
180 patients are needed to obtain statistically significant differences between both groups. Qualitative variables are expressed in the form of frequencies and percentages and continuous variables in the form of means and standard deviations. Comparisons of percentages will be made by the Chi square test (or Exact Fisher's test, when the expected frequencies are less than 5) and the difference of means in the continuous variables by the t test as well as by the Wilcoxon nonparametric test if the distribution of the variable requires it. The degree of agreement between the BIS and Ramsay scale will be made through the weighted Kappa test. Statistical significance will be assumed when p \<0.05. All statistical analyzes will be carried out using SAS V9.4. (SAS institute, Inc., Carey, NC).
Exclusion Criteria:
Group of patients (90) in whom sedation is adjusted using as main parameters the information obtained by the BIS sedation monitor (BIS VISTA, Aspect Medical Systems, USA).
Device: BIS monitor
Group of patients (90) in whom sedation is based on subjective monitoring of the level of sedation, using the Ramsay scale as a reference.
Device: Ramsay scale
The investigators will place on the forehead of all patients the sensor BIS quatroTM, that connects with this monitor, and they will guide sedation and will record the values obtained.
Also known as: BIS VISTA; Aspect Medical Systems, USA
In this group, sedation is guided by the Ramsay monitoring scale. The investigators will talk with the patients and will determine the corresponding level of sedation.
Also known as: Conventional monitoring
Sedation-induced adverse events
Compare the rate of cardiorrespiratory adverse events between the two groups
Time frame: 1 year.
Characteristics of patients who developed adverse events
Describe the patient characteristics
Time frame: 1 year.
The pharmacological dosage
The investigators will note if there is significant differences in the dose of phamacological drugs, and rescue propofol
Time frame: 1 year.
Level of satisfaction with the colonoscopy.
The investigators will distribute a satisfaction questionnaire to all patients after the colonoscopy to find out their opinion about the quality of sedation.
Time frame: 1 year.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators have a randomization table to assign the intervention of each patient. The investigators will record anthropometric data and the parameters resulting from the monitoring. These data will be available to collaborating investigators and subsequently to a member of the Research Unit who will record this information in a database that will be analyzed to obtain results.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Hospital Galdakao-Usansolo