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Comparison of propofol-nalbuphine and propofol-magnesium sulphate sedation for patients undergoing GIT endoscopy: a double-blind, randomized trial
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propofol and nalbuphine group | Active Comparator |
| |
| Propofol and magnesium sulfate group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol and magnesium sulphate ,propofol and nalbuphine | Drug | The patients will be randomly divided into 2 groups by using a computer-generated randomization tableAll patients will fast from solids for 8 h and from liquids for 2 h. After arrival at preoperative area an intravenous cannula will be placed in the peripheral vein of right hand for fluid infusion and medicine administration. All of the patients will be interviewed by the patient sedation satisfaction assessment tool (PSSI) regarding their experience 1 hour after the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| The level of patient sedation | 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. | the time of endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noura Hasan Attia, Master Degree | Contact | 01002640938 | nourahasan289@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hamdy Abbas Youssef, Professor | Assiut University | Study Director |
| Ola Mahmoud Wahba, Assistant Professor | Assiut University | Study Director |
| Khaled Tolba Younes, Lecturer |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18843709 | Background | Singh H, Poluha W, Cheung M, Choptain N, Baron KI, Taback SP. Propofol for sedation during colonoscopy. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD006268. doi: 10.1002/14651858.CD006268.pub2. | |
| 16278131 | Background | Rex DK, Khalfan HK. Sedation and the technical performance of colonoscopy. Gastrointest Endosc Clin N Am. 2005 Oct;15(4):661-72. doi: 10.1016/j.giec.2005.08.003. |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Assiut University |
| Study Director |
| 28877145 | Background | Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |