Bispectral Index Monitoring During Anesthesiologist - Directed Sedation in Scheduled Colonoscopies

Completed

• Conditions: Colonoscopy
• Interventions: Device: BIS monitor

• Registration Number: NCT03461029
• Lead Sponsor: Hospital Galdakao-Usansolo

Brief Summary

The aim of the study is to establish and identify the level of sedation that is performed in the endoscopy rooms of Galdakao Hospital. To do this, the investigators used the BIS monitoring system, which obtains objective values in real time from the anesthesia performed. The monitoring is completed with basic parameters validated by European guidelines (heart rate, blood pressure, oxygen saturation and respiratory rate), capnography and Ramsay sedation scale, widely validated for use outside the operating room. The main work hypothesis was that in at least 10% of the patients BIS values compatible with moderate or deep sedation would be obtained (BIS \<65).

Detailed Description

Observational study in patients undergoing scheduled colonoscopy in endoscopy rooms of the Galdakao-Usansolo Hospital. The investigators objectified the level of sedation that was performed in these procedures using Bispectral Index Monitoring, as well as the total dose of medication required and the level of satisfaction obtained after completing the sedation. The incidence of hemodynamic and respiratory complications observed was included, as well as the treatment needed to solve them.

A total of 196 patients were needed to obtain statistically significant results. Qualitative variables are expressed in the form of freguencies and percentages and continuous variables in the form of means and stnadard deviations. Comparisions of percentages were made by the Chi square test and the difference of means in the continuous variables by the t test.Stadistical significance will be assumed when p\<0.05. All estadistical analyzes were carried out using SAS V9.4 (SAS Institute, Inc., Carey, NC).

Study Timeline

• Study Start: 2016-01-30
• Primary Completion: 2017-12-30
• Status Verified: 2018-02
• Study Completion: 2018-02-20
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Study First Posted: 2018-03-09
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Indication of scheduled colonoscopy.
• Classification of physical status ASA I, II and III.
• Intermitent or persistent mild asthma.
• Body Mass Index (BMI) < 35 kg/m2.
• Intact neurological capacity.
• Acceptance to participate in the study after signing written informed consent.

Exclusion Criteria

• ASA IV.
• BMI > 35 kg/m2.
• Allergy to any of the medications using in sedation, or its components.
• Known mental or neurological disease.
• Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
• Chronic opiate users.
• Refusal to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIS	BIS monitor	Group of 196 patients in whom sedation monitoring is performed using the Bispectral Index Monitoring (BIS) system.

Primary Outcome Measures

Name	Time	Method
Level of sedation	1 year.	Sedation measured by Bispectral Index Monitoring.

Secondary Outcome Measures

Name	Time	Method
Complications related to sedation.	1 year.	Complications were measured: hypotension, bradicardia, apnea and low oxygen saturation. The medications or maneuvers that were necessary to correct these complications were also evaluated.
Level of satisfaction with the sedation.	1 year.	The investigators distributed a satisfaction questionnaire to all patients after colonoscopy to find their opinion about the quality of sedation.

Trial Locations

Locations (1)

Hospital Galdakao-Usansolo; 🇪🇸 Galdakao, Vizcaya, Spain