Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

ConditionAnesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAl-Balqa Applied University

About this trial

It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients of both genders

Age between 18 and 85 years old

Referred to standard upper endoscopy at Luzmila Hospital

Disqualifiers

Patients who are pregnant,

Known allergies to the used drugs

History of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension)

Previous history of gastrectomy,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propofol 100 MG in 10 ML Injection

    Drug

    Sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes), any involuntary patient movement, quality of sedation (VAS) and adverse events

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Continuous infusion (CI group) of propofolActive comparator 1 intervention
Group B: Intermittent bolus injection (BI group) of propofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sedation induction time (minutes)

Sedation induction time (minutes) is the time measured from the deep sedation induction until the patient is deeply sedated

Time frame
30 minutes
2

Total dose of propofol (mg)

Total dose of propofol (mg) used during the upper endoscopy procedure

Time frame
30 minutes
3

Recovery time (minutes)

Recovery time (minutes) is the time used for the patients to open their eyes after stoping sedation

Time frame
30 minutes

Secondary outcomes

1

Involuntary movement

Any involuntary patient movement during the endoscopy procedure under deep sedation

Time frame
30 minutes
2

Quality of sedation

How deeply is the patient sedated (VAS) as assessed by the endoscopist (1 good, 2 moderate, 3 poor)

Time frame
30 minutes
3

Adverse events

Any adverse events occurring during the procedure such as apnea, dyspnea, hiccups, jerky movements...etc

Time frame
30 minutes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Al-Balqa Applied University

Lead sponsor

Luzmila Hospital

Collaborator

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