Monitored Anesthesia Care With Propofol Plus Remifentanil During Endoscopic Submucosal Dissection: Evaluation of Bispectral Index Monitoring

Yonsei University

Status: Completed

Conditions: Early Gastric Cancer

Treatments: Device: BIS sensor attachment; Drug: no- BIS sensor attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT01921283

4-2011-0347

Details and patient eligibility

About

There are clinical usefulness issues associated with bispectral index (BIS) for sedation of endoscopic submucosal dissection (ESD). However, the clinical usefulness of BIS for deep sedation is incompletely described. The purpose of this study is to show that BIS-guided sedation is safe and useful clinically and may provide stable sedation status to physicians and patients.

Enrollment: 180 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status I to II.

Exclusion criteria

• body mass index (BMI) over 35 (Kg/m2)
• hepatic or renal insufficiency
• history of allergy to the drugs used
• history of administration of anxiolytics, narcotics, antipsychotics, opioid.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

BIS group

Experimental group

Description:

The BIS group (n=90) was monitored for sedation depth using BIS during ESD.

Treatment:

Device: BIS sensor attachment

No-BIS group

Active Comparator group

Description:

The no-BIS group (n=90) was monitored by observer's assessment alertness/sedation scale (OAA/S).

Treatment:

Drug: no- BIS sensor attachment