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Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06378879
Enrollment
100
Registered
2024-04-23
Start date
2024-09-06
Completion date
2025-07-30
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Propofol, Dormicum, Infusion, Bolus, Gastroscopy

Brief summary

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.

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.

Interventions

DRUGPropofol 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

Sponsors

Luzmila Hospital
CollaboratorUNKNOWN
Al-Balqa Applied University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sedation induction time (minutes)30 minutesSedation induction time (minutes) is the time measured from the deep sedation induction until the patient is deeply sedated
Total dose of propofol (mg)30 minutesTotal dose of propofol (mg) used during the upper endoscopy procedure
Recovery time (minutes)30 minutesRecovery time (minutes) is the time used for the patients to open their eyes after stoping sedation

Secondary

MeasureTime frameDescription
Involuntary movement30 minutesAny involuntary patient movement during the endoscopy procedure under deep sedation
Quality of sedation30 minutesHow deeply is the patient sedated (VAS) as assessed by the endoscopist (1 good, 2 moderate, 3 poor)
Adverse events30 minutesAny adverse events occurring during the procedure such as apnea, dyspnea, hiccups, jerky movements...etc

Contacts

Primary ContactTarek Mazzawi, MD, PhD
tarek.mazzawi@bau.edu.jo+962795698164
Backup ContactFayez Alhadidi, MD
+962795502133

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026