Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

NCT ID: NCT06378879

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-06
• Study Completion Date: 2025-07-30

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.

Conditions

Anesthesia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Propofol 100 MG in 10 ML Injection

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Propofol 100 MG in 10 ML Injection

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Diprivan (100mg/10ml)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Luzmila Hospital

UNKNOWN

Sponsor Role: collaborator

Al-Balqa Applied University

OTHER

Sponsor Role: lead

Responsible Party

Tarek Mazzawi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Mazzawi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Al-Balqa Applied University

Central Contacts

Tarek Mazzawi, MD, PhD

Role: CONTACT

tarek.mazzawi@bau.edu.jo

+962795698164

Fayez Alhadidi, MD

Role: CONTACT

+962795502133

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Related Links

http://www.bau.edu.jo

University website

Other Identifiers

1073/1/3/26

Identifier Type: -

Identifier Source: org_study_id