An interventional study of Propofol Injection [Diprivan] and Dexmedetomidine [Precedex] in Gastro-Intestinal Disorder, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
Upper gastrointestinal tract endoscopy (UGIE) is a valuable procedure that is commonly used for the diagnosis of possible causes of upper gastrointestinal tract (GIT) symptoms such as bleeding, pain, dysphagia, recurrent vomiting and reflux. Moreover, it is a safe and easy procedure for taking biopsy samples for suspected esophageal, gastric and duodenal diseases, grading and even ligating varices [1, 2].
UGIE is widely performed under propofol sedation that considered a safe sedation technique and alleviates the sympathetic response to the procedure. However, gag reflex and retching still exist in approximately 29% of those patients despite being under propofol sedation [3]. Any further trial of deepening sedation in order to minimize gagging may compromise hemodynamics and cause respiratory depression. These complications add to the overall costs as it increases morbidity and duration of patients' hospitalization. On the other hand, continued gag reflex could affect the safety of the procedure, patient's tolerance and endoscopist's satisfaction [4].
Dexmedetomidine, a short-acting selective α2-agonist, has been used frequently as a sedoanalgesic in many diagnostic and therapeutic procedures [5]. It provides unique sedative activity not present in conventional sedatives so it is unlikely to cause restlessness or respiratory depression was seen with Gaba aminobutyric acid (GABA) receptor agonists such as propofol. Therefore it minimizes physical and emotional distress and enhances successful completion of the procedure without remarkable gag reflex [6]. However, many clinicians may have qualms regarding the safety profile of dexmedetomidine usage in such endoscopic procedures due to its well known hemodynamic side effects (especially bradycardia and hypotension) [7].
Topical pharyngeal anesthesia(TPA) has been used to avoid such complications resulting from deepening sedation through increase i.v anesthetic doses of propofol or adjuvants that may be used as dexmedetomidine. TPA is preferred in many centers, particularly for diagnostic endoscopy [8, 9].
Lidocaine is widely used for TPA. The spray, gel and inhaler forms of it are commercially available. However, application of lidocaine gel to the oral cavity and the oropharynx, especially the base of the tongue, palate, uvula, palatopharyngeal, palatoglossal folds and posterior pharyngeal wall will attenuate or even abolish the gag reflex while introducing the UGIE, thus increasing the patient's comfort and tolerance to the procedure and decreasing the dose of i.v. anesthetics with their potential complications [10, 11].
Palatable lidocaine gel is a local anesthetic that stabilizes the neuronal membrane through hindering the ionic fluxes that initiate and transmit impulses, thereby giving a local anesthetic action. It is a safe, well-tolerated and quite promising TPA particularly in elderly patients and in patients with comorbidities in office-based endoscopy [12].
We hypothesize that the usage of topical palatable lidocaine gel may have an impact on decreasing the incidence of gag reflex and total propofol consumption during upper gastrointestinal endoscopy.
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Exclusion Criteria:
patients will receive propofol 50 mg
Drug: Propofol Injection [Diprivan]
patients will receive propofol 50 mg + dexmedetomidine 0.5 mcg/ kg
Drug: Dexmedetomidine [Precedex]
patients will receive propofol 50 mg +15 g palatable lidocaine gel
Drug: Palatable Lidocaine Topical Gel
patients will be sedated with 50 mg propofol(10 mg/ml) given slowly intravenously over 1 min
patients will received 0.5 mcg/ kg dexmedetomidine intravenously followed by syringe containing 50 mg propofol(10 mg/ml).
Also known as: propofol
15 g of palatable lidocaine gel will be gradually applied 3-5 min before the endoscopy at three consecutive 30-s intervals to the base of the tongue, the palate and the peritonsillar areas and the patients will be informed to spread it within their mouth with their tongue and swallow it later to cover the oropharynx and esophagus. Patients will be asked to register the onset of numbness, then patient will receive syringe containing 50 mg propofol (10 mg/ml) intravenously as a sedation.
Also known as: propofol
Gag reflex
will be assessed as ''present or not" when a vomiting like response will provoked upon introduction of the endoscope.
Time frame: through endoscopic procedure up to one hour
heart rate
Intraoperative hemodynamics
Time frame: every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.
mean blood pressure
Intraoperative hemodynamics
Time frame: every 2 min for the first 10 min of the procedure, then every 5 min till the end of the procedure.
Patient's satisfaction regarding discomfort (gagging and pain)
will be assessed using numerical rating scale from 1 to 10 (1=satisfied and tolerated well the procedure to 10=unsatisfied)
Time frame: 2 hours post the procedure
Endoscopist's satisfaction regarding gagging and difficulty of performing the procedure
using numerical rating scale from 1 to 10 (1=no gagging/difficulty to 10=maximum gagging/ difficulty)
Time frame: through endoscopic procedure up to one hour
Plan to share: Yes — planned after the completion of the study and publication
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Zagazig University