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

NCT02792751 | Completed

• 1 other identifier: 123
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oxidative Stress

Keywords

Depth of anesthesia; BIS; ERCP; Positive Regulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group R (Ramsey)=25 patients

ACTIVE COMPARATOR

Propofol infusion was administered to provide Ramsey Sedation Scale 3-4 in Group R

Other: Ramsey Sedation Scale

Group B (BIS)=25 patients

EXPERIMENTAL

Propofol infusion was given to maintain the Bispectral index monitorisation (BIS) levels between 60 and 85 in Group B.

Device: Bispectral Index Monitorisation (BIS)

Interventions

Bispectral Index Monitorisation (BIS) DEVICE

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

Group B (BIS)=25 patients

Ramsey Sedation Scale OTHER

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

Group R (Ramsey)=25 patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American Society of Anesthesiologists physical status I-II
• Patients undergoing ERCP procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 24, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share