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

Antalya Training and Research Hospital

Status: Completed

Conditions: Oxidative Stress

Treatments: Device: Bispectral Index Monitorisation (BIS); Other: Ramsey Sedation Scale

Study type: Interventional

Funder types: Other

Identifiers

NCT02792751

123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group R (Ramsey)=25 patients

Active Comparator group

Description:

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

Treatment:

Other: Ramsey Sedation Scale

Group B (BIS)=25 patients

Experimental group

Description:

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

Treatment:

Device: Bispectral Index Monitorisation (BIS)