Faculty of Medicine
Cairo, Shebin El-kom, 32511, Egypt
NCT Number: NCT03925779
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Cairo, Shebin El-kom, 32511, Egypt
Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dexmedetomidine sedation
Other names: dexmedetomidine infusion
propofol sedation
Other names: propofol infusion
Remifentanil sedation
Other names: Remifentanil infusion
Time frame: Perioperative
Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
Time frame: Perioperative
Mean arterial blood pressure in mmHg
Time frame: Perioperative
Heart rate in beats/minutes
Time frame: Perioperative
Arterial oxygen saturation as a percentage of the total haemoglobin.
Time frame: Perioperative
Number of patients with hypotension
Time frame: Perioperative
Number of patients with bradycardia
Time frame: Perioperative
Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]
Menoufia University
Other
Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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