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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02792751
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oxidative Stress Device: Bispectral Index Monitorisation (BIS) Other: Ramsey Sedation Scale Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Bispectral Index on Oxidative Stress
Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Active Comparator: Group R (Ramsey)=25 patients
Propofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R
Other: Ramsey Sedation Scale
Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4

Experimental: Group B (BIS)=25 patients
Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B.
Device: Bispectral Index Monitorisation (BIS)
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

Primary Outcome Measures :
  1. Effects of BIS on oxidative stress [ Time Frame: one day ]
    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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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Responsible Party: Antalya Training and Research Hospital Identifier: NCT02792751     History of Changes
Other Study ID Numbers: 123
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share data
Keywords provided by Antalya Training and Research Hospital:
Depth of anesthesia
Positive Regulation
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General