Comparison of Propofol-Nalbuphine and Propofol-Magnesium Sulphate Sedation for Patients Undergoing GIT Endoscopy
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 60
- Primary Endpoint
- The level of patient sedation
Study Overview
Brief Summary
Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial
Detailed Description
Endoscopy plays a significant role in the diagnosis and treatment of gastrointestinal diseases. Sedation has been used in clinical practice to make the procedure more comfortable, and improve patient satisfaction by helping patients rest during the procedure. (1) (2) The most common complications in gastrointestinal endoscopy are not related to the procedure, but are related to sedation; they include cardio-respiratory adverse events such as hypoxemia, hypoventilation, apnea, dysrhythmias, hypotension and vaso-vagal episodes (3).
Many studies have reported on use of propofol as a single agent for sedation during endoscopy. However propofol is often used in combination with another agent for other indications. The benefit of propofol in terms of shorter recovery and discharge times and higher patient satisfaction persists, when it is used in combination with other agents.
Propofol has limited analgesic effect and higher doses are often required, when it is used as a single agent for endonoscopy, resulting in higher sedation levels. Thus use of propofol in combination with other agents may be preferable to propofol alone. The combination may be easier to manage due to lower sedation levels and ability to reverse some of the sedation with the use of reversal agents for narcotics (4).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients scheduled for GIT endoscopy
- •Age 18-60 years old
- •BMI less than 30
Exclusion Criteria
- •Heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
- •pulmonary disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, or lung cancer)
- •central nervous system abnormality
- •allergy to the study drugs
- •habitual sedative or analgesic use
- •Anticipated difficult airway.
Arms & Interventions
propofol and nalbuphine group
Intervention: propofol and magnesium sulphate ,propofol and nalbuphine (Drug)
Propofol and magnesium sulfate group
Intervention: propofol and magnesium sulphate ,propofol and nalbuphine (Drug)
Outcomes
Primary Outcomes
The level of patient sedation
Time Frame: the time of endoscopy
The level of patient sedation using Ramsay sedation agitation score (before induction of sedation (T0), 5 minutes after sedation (T1), 10 minutes after sedation (T2), and then every 30 minutes till complete recovery (T3, T4 and T5) to assess the depth of anesthesia.
Secondary Outcomes
No secondary outcomes reported
Investigators
Noura Hasan Attia
Assistant Lecturer
Assiut University