Skip to content

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

Effects of Bispectral Index on Oxidative Stress

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02792751
Enrollment
50
Registered
2016-06-08
Start date
2014-05-31
Completion date
2015-10-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Depth of anesthesia, BIS, ERCP, Positive Regulation

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.

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.

Interventions

DEVICEBispectral 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

Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Effects of BIS on oxidative stressone dayThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026