Does the Use of Bispectral Index Reduce the Oxidative Stress in Endoscopic Retrograde Cholangiopancreatography?

Study Overview
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Brief Summary
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Objective Endoscopic Retrograde Cholangiopancreatography (ERCP) is performed for resolving cholestasis by sphincterotomy and/or stone extraction and is done with deep sedation or general anesthesia. The investigators primary outcome was to evaluate the effects of the depth of anesthesia on oxidative stres provided via Bispectral Index (BIS) monitorisation during the ERCP procedure by analyzing the biochemical parameters. And their secondary outcome was the effects of anesthesia depth on propofol consumption and postoperative sedation status.

Detailed Description
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50 patients undergoing ERCP procedure were randomly allocated in two groups. Propofol was given to provide the patients Ramsey sedation scale as 3 and 4 in Group R (n=25) patients whereas it was given to Group B (n=25) patients to provide BIS values between 65 to 85. The levels of total oxidant status (TOS), total antioxidant status (TAS), and Oxidative stres index (OSI) were measured. Hemodynamic signs, propofol consumption, postoperative recovery time were recorded.

Official Title
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Effects of Bispectral Index on Oxidative Stress

Conditions
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Oxidative Stress

Intervention / Treatment
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* Device: Bispectral Index Monitorisation (BIS)
* Other: Ramsey Sedation Scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with American Society of Anesthesiologists physical status I-II Patients undergoing ERCP procedures Exclusion Criteria: uncontrolled comorbidities (hypertension, diabetes mellitus, kidney-liver failure) difficulty in communication (language problems, such as deafness) who are allergic to the drugs used pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group R (Ramsey)=25 patients<br>Propofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R | Other: Ramsey Sedation Scale<br>* Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4<br>|
| Experimental: Group B (BIS)=25 patients<br>Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B. | Device: Bispectral Index Monitorisation (BIS)<br>* Standard monitoring was performed with electrocardiography, pulse oximetry and non invasive blood pressure. Additionally, Bispectral index (Aspect Medical Systems, Natica, MA) electrodes were connected to Group B patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of BIS on oxidative stress | The investigators aimed to investigate the effects of anesthesia with monitoring the depth of anesthesia using BIS on oxidative stres by measuring the total oxidant status (TAS) and total antioxidant status (TOS) , propofol consumption, and postoperative recovery during ERCP procedures in this study. | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depth of anesthesia, BIS, ERCP, Positive Regulation