Last updated on March 2018

Bispectral Index Monitoring of Sedation in Spontaneous Ventilation. Clinical Trial in Scheduled Colonoscopies

Brief description of study

The aim of the study is to compare the monitoring of anesthetic depth in colonoscopies using the bispectral index monitor versus conventional monitoring as a guide for sedation, allowing to offer the best care in terms of patient safety. The investigators will choose non-obese adult patients without many pathologies and with intact neurological capacity. They must voluntarily participate in the study and sign the informed consent designed specifically for the study. The main hypothesis is that the percentage of optimal sedation in the group of patients guided by the monitoring of the bispectral index will be 20% higher than in the group guided in a conventional manner. The investigators expect significant differences in the incidence of complications, total dose of drugs and need for rescue medication. There will be no significant difference in the satisfaction with the colonoscopy.

Detailed Study Description

Randomized double-blind clinical trial in patients undergoing scheduled colonoscopies in endoscopy rooms of the Galdakao-Usnsolo Hospital. The investigators will compare the percentage of optimal sedation (defined as bispectral index -BIS- parameter between 65 and 85 or score on the Ramsay scale 2 or 3) as well as the need for rescue medication and incidence of complications among the experimental group in which sedation is guided by BIS and the control in which the anesthesiologist is blind to the result of the BIS. The investigators hope that the use of BIS decreases the chances throughout the colonoscopy in which it is necessary to increase the level of sedation.

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).

Clinical Study Identifier: NCT03453359

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Recruitment Status: Open

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