Opioid Effects on Cognitive Function Following Colonoscopy
Paraules clau
Resum
Descripció
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.
Dates
| Darrera verificació: | 05/31/2016 |
| Primer enviat: | 10/13/2014 |
| Inscripció estimada enviada: | 10/13/2014 |
| Publicat per primera vegada: | 10/16/2014 |
| Última actualització enviada: | 06/27/2016 |
| Publicació de l'última actualització: | 06/28/2016 |
| Data d'inici de l'estudi real: | 09/30/2014 |
| Data estimada de finalització primària: | 04/30/2016 |
| Data estimada de finalització de l’estudi: | 05/31/2016 |
Condició o malaltia
Intervenció / tractament
Drug: Group F
Drug: Group A
Drug: Propofol
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Group A 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. | Drug: Group A Intravenous alfentanyl for sedation/analgesia |
| Experimental: Group F 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 can not tolerate the procedure. | Drug: Group F Intravenous fentanyl for sedation/analgesia |
| Active Comparator: Group P 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. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - Ages between 18-65 - American Society of Anesthesiologists classification I-III - Patients scheduled to undergo elective colonoscopy or endoscopy and colonoscopy Exclusion Criteria: - Patients younger than 18 or older than 65 - Mini mental test score < 26 - APAIS (The Amsterdam Preoperative Anxiety and Information Scale) >10 - Serious systemic disease - Neuropsychiatric disorder - Chronic alcohol abuse - Morbid obesity - History of anesthesia in the last 7 days - Known allergy to study drugs |
Resultat
Mesures de resultats primaris
1. cognitive dysfunction [during the 30 minutes after the termination of the procedure]
Mesures de resultats secundaris
1. Patient and endoscopist satisfaction [following the procedure]
2. Pain [during the 30 minutes after the termination of the procedure]
3. Side effects [during the 30 minutes after the termination of the procedure]
