Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

August 5, 2024 updated by: Tarek Mazzawi, Al-Balqa Applied University

Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fayez Alhadidi, MD
  • Phone Number: +962795502133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous infusion (CI group) of propofol
CI was defined by continuous propofol infusion at a 3 mg/ kg/h rate with induction using benzodiazepine (2 mg dormicum i.v.) to evaluate the effect of the drug and assess sedation induction time, total dose of propofol, recovery time, quality of sedation.
Drug: Propofol 100 MG in 10 ML Injection
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)
Active Comparator: Intermittent bolus injection (BI group) of propofol
BI was defined by intermittent use of 20 mg propofol boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug and assess sedation induction time, total dose of propofol, recovery time, quality of sedation.
Drug: Propofol 100 MG in 10 ML Injection
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes
Total dose of propofol (mg)
Time Frame: 30 minutes
Total dose of propofol (mg) used during the upper endoscopy procedure
30 minutes
Recovery time (minutes)
Time Frame: 30 minutes
Recovery time (minutes) is the time used for the patients to open their eyes after stoping sedation
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Involuntary movement
Time Frame: 30 minutes
Any involuntary patient movement during the endoscopy procedure under deep sedation
30 minutes
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)
30 minutes
Adverse events
Time Frame: 30 minutes
Any adverse events occurring during the procedure such as apnea, dyspnea, hiccups, jerky movements...etc
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Balqa Applied University

Collaborators

Luzmila Hospital

Investigators

  • Principal Investigator: Tarek Mazzawi, MD, PhD, Faculty of Medicine, Al-Balqa Applied University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 6, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1073/1/3/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The analysis and results will be published in peer-reviewed journal. Study protocol, statistical analysis plan, informed consent will be provided upon request.

IPD Sharing Time Frame

During 2025

IPD Sharing Access Criteria

According to publishing journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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