Digestive System DiseasesPhase 4NCT02267681
Opioid Effects on Cognitive Function Following Colonoscopy
A Phase 4 study testing Fentanyl, Alfentanil and Propofol in people with Digestive System Diseases and Disorientation, run by Perihan Ekmekçi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System Diseases, Disorientation
- What is being tested?
- Fentanyl, Alfentanil and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages between 18-65
- American Society of Anesthesiologists classification I-III
- Patients scheduled to undergo elective colonoscopy or endoscopy and colonoscopy
Who cannot join
- 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
Show all 9Show fewer
- Morbid obesity
- History of anesthesia in the last 7 days
- Known allergy to study drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ufuk University Dr Rıdvan Ege Hospital
Ankara, 06520
About this study
Official title: The Effects of Fentanyl and Alfentanil as an Adjunct to Propofol on Cognitive Functions for Sedation in Colonoscopy
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.
Read the 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.
- Conditions
- Digestive System Diseases, Disorientation
- Medical subject headings
- Digestive System Diseases, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Talinat
Intravenous fentanyl for sedation/analgesia
AlfentanilDrug
Also called Rapifen
Intravenous alfentanyl for sedation/analgesia
PropofolDrug
Also called Diprivan
Intravenous propofol for sedation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Drug: Alfentanil; Drug: Propofol |
| Group F | Experimental | 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. Receives: Drug: Fentanyl; Drug: Propofol |
| Group P | Active comparator | 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. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive dysfunction
as evaluated using Trieger dot test,Mini mental test and Digit symbol substitution test
Measured: during the 30 minutes after the termination of the procedure
Secondary outcomes (3)
Patient and endoscopist satisfaction
as evaluated using a 5-point Likert scale
Measured: following the procedure
Pain
as evaluated using VAS score
Measured: during the 30 minutes after the termination of the procedure
Side effects
hypotension, hypertension, bradycardia, tachycardia, apnea, nausea and vomiting
Measured: during the 30 minutes after the termination of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Digestive System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perihan Ekmekçi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Perihan Ekmekçi, Ufuk University
- Investigators
- Perihan Ekmekçi, MD, Principal investigator, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267681
- Sponsor's protocol ID
- Ufuk University
- Status last verified
- Jun 2016
- First submitted
- 14 Oct 2014
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinically relevant complications and monitoring of endoscopy: results of a nationwide survey in Switzerland. Endoscopy. 1994 Feb;26(2):231-4. doi: 10.1055/s-2007-1008949.
PubMed 8026371Turk HS, Aydogmus M, Unsal O, Koksal HM, Acik ME, Oba S. Sedation-analgesia in elective colonoscopy: propofol-fentanyl versus propofol-alfentanil. Braz J Anesthesiol. 2013 Jul-Aug;63(4):352-7. doi: 10.1016/j.bjane.2012.07.007. Epub 2013 Aug 13.
PubMed 24565243
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fentanyl and Alfentanil as an Adjunct to Propofol on Cognitive Functions for Sedation in Colonoscopy
- ClinicalTrials.gov ID
- NCT02267681
- Acronym / sponsor ID
- Ufuk University
- Conditions
- Digestive System Diseases, Disorientation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Perihan EkmekçiUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Alfentanil, Drug: PropofolThe 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. |
| Group F | Experimental | Drug: Fentanyl, Drug: PropofolThe 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. |
| Group P | Active comparator | Drug: PropofolGroup 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 18-65
- American Society of Anesthesiologists classification I-III
- Patients scheduled to undergo elective colonoscopy or endoscopy and colonoscopy
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: TalinatIntravenous fentanyl for sedation/analgesia | Drug | Group F |
| AlfentanilAlso: RapifenIntravenous alfentanyl for sedation/analgesia | Drug | Group A |
| PropofolAlso: DiprivanIntravenous propofol for sedation | Drug | Group A, Group F, Group P |
Primary outcome
cognitive dysfunction
Time frame: during the 30 minutes after the termination of the procedure
as evaluated using Trieger dot test,Mini mental test and Digit symbol substitution test
3 secondary outcomes
Patient and endoscopist satisfaction
Time frame: following the procedure
Pain
Time frame: during the 30 minutes after the termination of the procedure
Side effects
Time frame: during the 30 minutes after the termination of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
- Background: PubMed 8026371Froehlich F, Gonvers JJ, Fried M. Conscious sedation, clinically relevant complications and monitoring of endoscopy: results of a nationwide survey in Switzerland. Endoscopy. 1994 Feb;26(2):231-4. doi: 10.1055/s-2007-1008949.
- Background: PubMed 24565243Turk HS, Aydogmus M, Unsal O, Koksal HM, Acik ME, Oba S. Sedation-analgesia in elective colonoscopy: propofol-fentanyl versus propofol-alfentanil. Braz J Anesthesiol. 2013 Jul-Aug;63(4):352-7. doi: 10.1016/j.bjane.2012.07.007. Epub 2013 Aug 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perihan Ekmekçi, MD principal investigator
Ufuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, Alfentanil and Propofol in people with Digestive System Diseases and Disorientation, run by Perihan Ekmekçi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive dysfunction (time frame: during the 30 minutes after the termination of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267681, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.