Opioid Effects on Cognitive Function Following Colonoscopy
Condition: Digestive System Diseases; Disorientation
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases; Confusion
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the effects of fentanyl and alfentanil on postprocedural cognitive
      function in elective endoscopy.

      150 patients will be enrolled in the study. Patients meeting eligibility criteria will be
      randomly allocated to three groups.

      The patients in Group A will be given propofol and alfentanil. The patients in Group F will
      be given propofol and fentanyl. Group P is designated as the control group and the patients
      will be given propofol for sedation.

      Awareness, vital signs and pain will be evaluated. Side effects will be recorded. Patient and
      endoscopist satisfaction will be evaluated.
    

Detailed description: 
      In this study we aimed to compare the effects of sedation provided by propofol with the
      addition of the short-acting opioid alfentanil and long-acting opioid fentanyl on cognitive
      functions, pain, side effects during the procedure and the endoscopist and patient
      satisfaction.

      Following the approval of Kırıkkale University ethics committee, 150 patients ages between 18
      and 65 ASA I-III scheduled for elective endoscopy and colonoscopy will be enrolled in the
      study.

      After obtaining written informed consent, APAIS (The Amsterdam Preoperative Anxiety and
      Information Scale) and MMTS (Mini Mental Test Scoring) tests will given to patients.
      Following TDT (Trieger Dot Test) and DSST (Digit Symbol Substitution Test), the patients will
      be randomly allocated to either Propofol-Alfentanil (Group A), Propofol-Fentanyl (Group F) or
      Propofol-Control (Group P) which consists of 50 patients each.

      The patients in Group A will be given 100 mcg/kg/min propofol infusion and 10 mcg/kg loading
      dose of alfentanil and 5 mcg/kg additional bolus of alfentanil whenever FPS (Faces Pain
      Scale) is greater than 3 or the patients can not tolerate the procedure.

      The patients in Group F will be given 100 mcg/kg/min propofol infusion and 1 mcg/kg loading
      dose of fentanyl and 5 mcg/kg additional bolus of fentanyl whenever FPS (Faces Pain Scale) is
      greater than 3 or the patients could not tolerate the procedure.

      Group P is designated as the control group and the patients will be given 100mcg/kg/min
      infusion and sedation will be achieved via 1 mg/kg propofol loading dose and 0.5 mg/kg
      propofol additional bolus will be given whenever the patients can not tolerate the procedure
      or FPS is greater than 3.

      BIS values, mean arterial pressures, heart rates, peripheral oxygen saturations will be
      recorded in all three groups. FPS and VAS (Visual Analogue Scale) values will be evaluated.

      Patients with intraprocedural desaturation, hypo- or hypertension, brady- or tachycardia,
      nausea, vomiting and apnea will be recorded. Total amounts of drugs administered will be
      recorded.

      Infusions will be ceased at the end of the procedure and the time for OAAS/S to exceed 3 will
      be recorded and TDT and DSST will be repeated at 5, 15 and 30th minutes. Patient and
      endoscopist satisfaction will be evaluated in all cases.
    

Intervention name(s): Fentanyl; Alfentanil; Propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous fentanyl for sedation/analgesia; Intravenous alfentanyl for sedation/analgesia; Intravenous propofol for sedation
Other intervention name(s): Talinat; Rapifen; Diprivan
Intervention MeSH terms: Fentanyl; Alfentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)