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NCT Number: NCT06378879

Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

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.

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Key information

Conditions

Anesthesia

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients of both genders, aged between 18 and 85 years old and referred to standard upper endoscopy at Luzmila Hospital will be included in the study. Patients who are pregnant, have known allergies to the drugs used or a history of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension) or gastrectomy, are American Society of Anesthesiologist (ASA) class ≥ IV (11), or are unable to provide informed consent will be excluded from participating in the study. The patients undergoing a standard upper endoscopy will be randomly assigned to either continuous infusion (CI group) of propofol (Diprivan) with induction using benzodiazepine (2 mg Dormicum i.v.) or only intermittent bolus injection (BI group) of propofol (Diprivan) infused by an anesthesiologist. BI was defined by intermittent use of 20 mg propofol (Diprivan) boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug. CI was defined by continuous propofol (Diprivan) infusion at a 3 mg/ kg/h rate.

The anesthesiologist will follow up the patient during the first observation period, the average time spent in the recovery area and register the requied data during the procedure using Aldrete score (a post anesthesia recovery score where a minimum score of 8 is required for discharge).

The patients' identities will be coded and the data will be kept confidential. The study protocol will be performed according to the Decalrations of Helsinki and will be applied for approval by the Institutional Review Board at Al-Balqa Applied University. Written informed consent was obtained from all patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both genders
  • Age between 18 and 85 years old
  • Referred to standard upper endoscopy at Luzmila Hospital

Exclusion criteria

  • 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,
  • Patients are American Society of Anesthesiologist (ASA) class ≥ IV ,
  • Patients are unable to provide informed consent

Treatment and study plan

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

Other names: Diprivan (100mg/10ml)

Primary outcomes

  1. Sedation induction time (minutes)

    Time frame: 30 minutes

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

  2. Total dose of propofol (mg)

    Time frame: 30 minutes

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

  3. Recovery time (minutes)

    Time frame: 30 minutes

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

Secondary outcomes

  1. Involuntary movement

    Time frame: 30 minutes

    Any involuntary patient movement during the endoscopy procedure under deep sedation

  2. Quality of sedation

    Time frame: 30 minutes

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

  3. Adverse events

    Time frame: 30 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fayez Alhadidi, MD

CONTACT

+962795502133

Tarek Mazzawi, MD, PhD

CONTACT

[email protected]

+962795698164

Sponsors and collaborators

Lead sponsor

Al-Balqa Applied University

Other

Collaborators

  • Luzmila Hospital

Registry information

Official study title

Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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