Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-10-30

Brief Summary

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Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy

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Detailed Description

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This study divide patients into two groups, one will be given propofol midazolam and fentanyl; another group was given propofol with midazolam without fentanyl; to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomly assigned to group A or B. Participants of group A are given propofol midazolam and fentanyl; while participants of group B are given propofol with midazolam without fentany

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control group

Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam

Group Type ACTIVE_COMPARATOR

50-200mg propofol

Intervention Type DRUG

participants in both groups are given standard regimen including 50-200mg propofol.

1 mg midazolam

Intervention Type DRUG

participants in both groups are given standard regimen including 1 mg midazolam.

Fentanyl group

Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.

Group Type EXPERIMENTAL

50-200mg propofol

Intervention Type DRUG

participants in both groups are given standard regimen including 50-200mg propofol.

50ug fentanyl

Intervention Type DRUG

participants in fentanyl group are given intervention regimen: 50ug fentanyl.

1 mg midazolam

Intervention Type DRUG

participants in both groups are given standard regimen including 1 mg midazolam.

Interventions

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50-200mg propofol

participants in both groups are given standard regimen including 50-200mg propofol.

Intervention Type DRUG

50ug fentanyl

participants in fentanyl group are given intervention regimen: 50ug fentanyl.

Intervention Type DRUG

1 mg midazolam

participants in both groups are given standard regimen including 1 mg midazolam.

Intervention Type DRUG

Other Intervention Names

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Jingan, J20110055 Yichang, H42022076 Liyuexi, H10980025

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 or older
* Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.

Exclusion Criteria

* Patients with a history of colorectal surgery
* Patients with ASA class 4 or 5,
* Patients with pre-existing hypoxaemia (SpO2\<90%),
* Patients with hypotension (SBP\<90mmHg)
* Patients with bradycardia (HR\<50 bpm)
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with pregnancy or lactation
* Patients hemodynamically unstable
* Patients unable to give informed consent
* Patients with a history of drug allergies;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes