Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378879
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-30
Brief Title:
Intermittent Boluses Versus Infusion of Propofol During Gastroscopy
Sponsor:
Al-Balqa Applied University
Organization:
Al-Balqa Applied University
Study Overview
Official Title:
Intermittent Boluses Versus Continuous Infusion of Propofol During Standard Upper Endoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 iv 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 kgh 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None