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

NCT05773807 | Completed

• 1 other identifier: 2019-1029
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the incidence of moderate to severe body movement during gastroscopy

  Moderate to severe body movement is defined as the twisting of the patient's body due to the stimulation of the gastroscopy, making it difficult to proceed with the procedure without additional propofol.

  The time during gastroscopy, an average of 15 minutes

Secondary Outcomes (7)

• The time of gastroscopy

  The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes

• Endoscopist satisfaction scores

  At the end of the gastroscopy

• The incidence of hypotension

  The time during gastroscopy, an average of 15 minutes

• The incidence of bradycardia

  The time during gastroscopy，an average of 15 minutes

• The incidence of hypoxemia

  The time during gastroscopy，an average of 15 minutes

Study Arms (2)

BIS group

EXPERIMENTAL

In the BIS 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 to maintain the BIS value at 45-60.

Other: Bispectral index; Procedure: Gastroscopy; Drug: Propofol

OAAS/S group

PLACEBO COMPARATOR

In the OAAS/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.

Other: Observer's assessment alert Sedation; Procedure: Gastroscopy; Drug: Propofol

Interventions

Bispectral index OTHER

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.

Also known as: BIS group

BIS group

Observer's assessment alert Sedation OTHER

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.

Also known as: OAA/S group

OAAS/S group

Gastroscopy PROCEDURE

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

Also known as: Electronic Gastroscopy

BIS group; OAAS/S group

Propofol DRUG

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

Also known as: Propofol infusion

BIS group; OAAS/S group

Eligibility Criteria

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

You may qualify if:

• ≤Age≤65 years old
• American Society of Anaesthesiologists (ASA) Physical Status of I - II
• ≤BMI≤30 kg/m²
• Outpatient patients who planned to undergo painless gastroscopy under propofol anesthesia

You may not qualify if:

• Patients with communication disorders
• Patients with alcohol and drug abuse or allergic or contraindicated drugs related to this trail
• Patients who take anti-anxiety, depression or sedative drugs
• Patients who participated in or were participating in other clinical trials within 3 months

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Consciousness Monitors; Gastroscopy; Propofol

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chunling Jiang, PhD

  China, Sichuan West China Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 17, 2023
• Study Start: January 1, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)