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

Oxidative Stress Clinical Trial

Official title:

Effects of Bispectral Index on Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792751
• Other study ID #: 123
• Status: Completed
• Phase: N/A
• First received: May 27, 2016
• Last updated: January 23, 2017
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

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

Other:
• Ramsey Sedation Scale
Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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