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Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy

NCT05773807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-03-17

No results posted yet for this study

Summary

Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the OAA/S group.

In the BIS group, the anesthesiologist set the target controlled infusion（TCI）parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5 ug/ml, and the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group, the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the OAA/S value at 1 point.

Conditions

  • Gastroscopy

Interventions

OTHER

Bispectral index

In the BIS group, the anesthesiologist set the target controlled infusion (TCI) parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ ml every two minutes to maintain the BIS value at 45-60.

OTHER

Observer's assessment alert Sedation

In the OAA/S group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ ml every two minutes maintain the OAA/S value at 1 point.

PROCEDURE

Gastroscopy

Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1

DRUG

Propofol

Propofol infusion was administered under the guidance of the BIS or OAA/S before the gastroscopy, and the infusion was stopped at the end of gastroscopy

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Chunling Jiang, PhD · China, Sichuan West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-02-15
Completion
2023-02-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773807 on ClinicalTrials.gov