Intravenous InfusionsNCT05522127
Restritive and Liberal Fluid Management and Colonoscopy
A study testing Colonoscopy and Sedoanalgesia in people with Intravenous Infusions and Colonoscopy, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
intraduction and aim In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Infusions, Colonoscopy, Sedoanalgesia
- What is being tested?
- Colonoscopy and Sedoanalgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2022to 30 Mar 2023
- Phase
- Interventional
- 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
- Signing the informed consent form
- Having irritable bowel disease, suspected colitis, unexplained iron deficiency and planning colonoscopy for screening
- Between the ages of 18-65
- According to the Physical Condition Classification of the American Society of Anesthesiologists, ASA I (a healthy person who does not cause normal systemic disorders, does not have a disease or systemic problem other than intestinal pathology) or ASA II (Person with mild systemic disorder due to a cause requiring intervention or another disease)
Who cannot join
- Not signing the informed consent form
- Not between the ages of 18-65
- Having epileptic seizures
- The use of drugs that affect the nervous system
- Having a history of allergic reaction to study drugs
- Long-term use of sedatives or sedatives
Show all 18Show fewer
- Receiving general anesthesia in the last 7 days
- Having adrenocortical insufficiency (hormone deficiency)
- Pregnancy
- Having a psychiatric disorder
- Having irritable bowel disease
- Presence of nausea, vomiting or dizziness before the procedure
- Being overweight
- Having a bad general condition
- Having had bowel surgery
- Being in the risky patient group (>ASA II)
- Alcohol addiction, inappropriate usage
- Multiple biopsies during the procedure, unwanted bleeding, changes in the amount of fluid to be given
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Zubeyde Hanim Practice and Research Center
Izmir, Karşıyaka, 35540
Özvardar Pekcan, +90 232 2411000 ext. 1085, yncapek@gmail.com
Tuncalı, +90 232 2411000 ext. 1260, tuncali.bahattin@gmail.com
About this study
Official title: A Comparison of Restrictive and Liberal Fluid Administration During Elective Colonoscopy Under Sedoanalgesia
intraduction and aim In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure.
Methods This study was planned to be conducted as a prospective, randomized (closed envelope method), controlled, double-blind study with 100 adult patients aged 18-65 years in the american sociological association (ASA I-II) risk group who will undergo colonoscopy under sedation-analgesia under elective conditions.Vascular access will be opened and randomly divided into two groups as Group R (Restrictive, 2ml/kg 0.9% Sodium cloride-NaCl during colonoscopy) and Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy). For sedoanalgesia, Midazolam 0.02 mg/kg, Fentanyl 1 μg/kg, Ketamine 0.3 mg/kg will be administered intravenous (IV), followed by 10 mg additional doses of propofol until the Ramsay sedation score (RSS) is 3-4. All colonoscopy procedures will be performed by the same gastroenterologist.
Expectations and scientific contributions This research may help to understand the effects of giving or not administering intravenous fluids (restrictive/liberal) prior to the procedure in patients undergoing elective colonoscopy under sedoanalgesia. It can provide hemodynamic stability, reduction in drug doses, reduction of side effects, rapid recovery and discharge, and reduction of costs.
Read the detailed description
intraduction and aim Intestinal cleansing and restriction of oral fluid intake in preparation for colonoscopy, which is one of the most frequently performed diagnostic procedures, may cause adverse hemodynamic effects during the procedure. These adverse effects can be prevented by intravenous fluid therapy. In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure.
Methods This study was planned to be conducted as a prospective, randomized (closed envelope method), controlled, double-blind study with 100 adult patients aged 18-65 years in the american sociological association (ASA) I-II risk group who will undergo colonoscopy under sedation-analgesia under elective conditions.
The patients will be taken to the endoscopy unit and hemodynamic monitoring will be applied. Vascular access will be opened and randomly divided into two groups as Group R (Restrictive, 2ml/kg 0.9% Sodium cloride-NaCl during colonoscopy) and Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy). For sedoanalgesia, Midazolam 0.02 mg/kg, Fentanyl 1 μg/kg, Ketamine 0.3 mg/kg will be administered intravenous (IV), followed by 10 mg additional doses of propofol until the Ramsay sedation score (RSS) is 3-4. All colonoscopy procedures will be performed by the same gastroenterologist.
During the colonoscopy procedure, patients will be given 3L/min oxygen with a face mask. Basal measurement values; heart rate, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, peripheral oxygen saturation (SpO2), respiratory rate and RSS will be recorded at regular intervals after sedation until the end of the colonoscopy attempt. Total midazolam, fentanyl, propofol, and ketamine doses, induction time, colonoscopy time, cecum intubation time, recovery time, and discharge time will be recorded. Possible hypoventilation, apnea, airway obstruction, hypotension, hypertension, arrhythmia, bradycardia, SpO2 falling below 95% and other side effects will be treated and recorded.
At the end of the procedure, the satisfaction of the gastroenterologist will be recorded. Patients with an RSS ≥2 will be admitted to the recovery unit, and patients with a postanesthetic discharge score of ≥9 will be sent home with an accompanying person. Recalls about the colonoscopy procedure by calling 24 hours after the procedure; Undesirable effects such as nausea, vomiting, pain, dizziness, drowsiness and satisfaction with the procedure will be questioned.
Expectations and scientific contributions This research may help to understand the effects of giving or not administering intravenous fluids (restrictive/liberal) prior to the procedure in patients undergoing elective colonoscopy under sedoanalgesia. It can provide hemodynamic stability, reduction in drug doses, reduction of side effects, rapid recovery and discharge, and reduction of costs.
- Conditions
- Intravenous Infusions, Colonoscopy, Sedoanalgesia
- Being tested
- Colonoscopy, Sedoanalgesia
- Keywords
- Sedoanalgesia, Colonoscopy, Intravenous Infusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyOther
Colonoscopy
SedoanalgesiaOther
Ketamine, fentanil, midazolam, propofol
| Study group | Role | What they receive |
|---|---|---|
| Group R (Restrictive) | Active comparator | Group R (Restrictive, 2ml/kg 0.9% NaCl during colonoscopy) Receives: Other: Colonoscopy; Other: Sedoanalgesia |
| Group L (Liberal ) | Active comparator | Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy) Receives: Other: Colonoscopy; Other: Sedoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.
Systolic blood pressure will be recoded.
Measured: During colonoscopy
Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopy
Diastolic blood pressure will be recoded.
Measured: During colonoscopy
Comparison of heart rate in restrictive and liberal patients in colonosopy
Heart rate will be recoded.
Measured: During colonoscopy
Comparison of spO2 in restrictive and liberal patients in colonosopy
spO2 will be recoded.
Measured: During colonoscopy
Comparison of procedure times in restrictive and liberal patients in colonosopy
Procedure times will be recoded.
Measured: During colonoscopy
Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopy
Total anaesthetic doses will be recoded.
Measured: During colonoscopy
Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy
Side effects will be recorded
Measured: 24 hours
Comparison of sedation levels in restrictive and liberal patients in colonosopy
Ramsey and modified post anaesthetic discharge score level will be recorded.
Measured: 24 hours
Secondary outcomes (2)
Patient satisfaction
Patient satisfaction will be assessed using a three point scale (satisfactory, moderate, not satisfactory) at the end of the procedure and after 24 hours via phone call. The patients will also be asked whether they have experienced any side effects (nausea, vomiting, abdominal pain, hallucination, double vision, etc.), and whether they would like to have the same sedoanalgesia procedure in the future colonoscopy procedures or not.
Measured: 24 hours
Gastroenterologist satisfaction
At the end of the procedure, the gastroenterologist's opinion about our sedoanalgesia method will be evaluated.using a three point scale (satisfactory, moderate or unsatisfactory)..
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start11 Oct 2022
- Primary completion1 Dec 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intravenous InfusionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonca Özvardar Pekcan, Baskent University
- Investigators
- Yonca Özvardar Pekcan, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522127
- Sponsor's protocol ID
- KA22/87
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trummel JM, Chandrasekhara V, Kochman ML. Anesthesia for Colonoscopy and Lower Endoscopic Procedures. Anesthesiol Clin. 2017 Dec;35(4):679-686. doi: 10.1016/j.anclin.2017.08.007.
PubMed 29101957Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.
PubMed 25801162das Neves JF, das Neves Araujo MM, de Paiva Araujo F, Ferreira CM, Duarte FB, Pace FH, Ornellas LC, Baron TH, Ferreira LE. Colonoscopy sedation: clinical trial comparing propofol and fentanyl with or without midazolam. Braz J Anesthesiol. 2016 May-Jun;66(3):231-6. doi: 10.1016/j.bjane.2014.09.014. Epub 2016 Mar 12.
PubMed 27108817Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
PubMed 28045707Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE; American Society of Colon and Rectal Surgeons; American Society for Gastrointestinal Endoscopy; Society of American Gastrointestinal and Endoscopic Surgeons. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Gastrointest Endosc. 2006 Jun;63(7):894-909. doi: 10.1016/j.gie.2006.03.918. No abstract available.
PubMed 167331016. Indrakrishnan I and Varatharajah T. Management of Endoscopy Patients' Hydration Status during National Shortage of Intravenous Fluids. J Gastroenterol Liver Dis 2016; 1: 1001
Leslie K, Allen M, Lee A, Clarke P. A randomized-controlled trial of high- or low-volume intravenous Plasma-Lyte((R)) to prevent hypotension during sedation for colonoscopy. Can J Anaesth. 2016 Aug;63(8):952-61. doi: 10.1007/s12630-016-0672-4. Epub 2016 May 18.
PubMed 27194403Leslie K, Tay T, Neo E. Intravenous fluid to prevent hypotension in patients undergoing elective colonoscopy. Anaesth Intensive Care. 2006 Jun;34(3):316-21. doi: 10.1177/0310057X0603400314.
PubMed 16802483Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.
PubMed 8534468
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Restrictive and Liberal Fluid Administration During Elective Colonoscopy Under Sedoanalgesia
- ClinicalTrials.gov ID
- NCT05522127
- Acronym / sponsor ID
- KA22/87
- Conditions
- Intravenous Infusions, Colonoscopy, Sedoanalgesia
- Keywords
- Sedoanalgesia, Colonoscopy, Intravenous Infusions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 30 Aug 2022 (actual)
- 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.
intraduction and aim In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure.
Methods This study was planned to be conducted as a prospective, randomized (closed envelope method), controlled, double-blind study with 100 adult patients aged 18-65 years in the american sociological association (ASA I-II) risk group who will undergo colonoscopy under sedation-analgesia under elective conditions.Vascular access will be opened and randomly divided into two groups as Group R (Restrictive, 2ml/kg 0.9% Sodium cloride-NaCl during colonoscopy) and Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy). For sedoanalgesia, Midazolam 0.02 mg/kg, Fentanyl 1 μg/kg, Ketamine 0.3 mg/kg will be administered intravenous (IV), followed by 10 mg additional doses of propofol until the Ramsay sedation score (RSS) is 3-4. All colonoscopy procedures will be performed by the same gastroenterologist.
Expectations and scientific contributions This research may help to understand the effects of giving or not administering intravenous fluids (restrictive/liberal) prior to the procedure in patients undergoing elective colonoscopy under sedoanalgesia. It can provide hemodynamic stability, reduction in drug doses, reduction of side effects, rapid recovery and discharge, and reduction of costs.
Detailed description
intraduction and aim Intestinal cleansing and restriction of oral fluid intake in preparation for colonoscopy, which is one of the most frequently performed diagnostic procedures, may cause adverse hemodynamic effects during the procedure. These adverse effects can be prevented by intravenous fluid therapy. In this study, in cases who will undergo elective day colonoscopy under sedoanalgesia; It was planned to investigate the effects of restrictive and liberal fluid administration on hemodynamics, side effects, drug levels, patient satisfaction, recovery and discharge times during the procedure.
Methods This study was planned to be conducted as a prospective, randomized (closed envelope method), controlled, double-blind study with 100 adult patients aged 18-65 years in the american sociological association (ASA) I-II risk group who will undergo colonoscopy under sedation-analgesia under elective conditions.
The patients will be taken to the endoscopy unit and hemodynamic monitoring will be applied. Vascular access will be opened and randomly divided into two groups as Group R (Restrictive, 2ml/kg 0.9% Sodium cloride-NaCl during colonoscopy) and Group L (Liberal 15ml/kg 0.9% NaCl during colonoscopy). For sedoanalgesia, Midazolam 0.02 mg/kg, Fentanyl 1 μg/kg, Ketamine 0.3 mg/kg will be administered intravenous (IV), followed by 10 mg additional doses of propofol until the Ramsay sedation score (RSS) is 3-4. All colonoscopy procedures will be performed by the same gastroenterologist.
During the colonoscopy procedure, patients will be given 3L/min oxygen with a face mask. Basal measurement values; heart rate, systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, peripheral oxygen saturation (SpO2), respiratory rate and RSS will be recorded at regular intervals after sedation until the end of the colonoscopy attempt. Total midazolam, fentanyl, propofol, and ketamine doses, induction time, colonoscopy time, cecum intubation time, recovery time, and discharge time will be recorded. Possible hypoventilation, apnea, airway obstruction, hypotension, hypertension, arrhythmia, bradycardia, SpO2 falling below 95% and other side effects will be treated and recorded.
At the end of the procedure, the satisfaction of the gastroenterologist will be recorded. Patients with an RSS ≥2 will be admitted to the recovery unit, and patients with a postanesthetic discharge score of ≥9 will be sent home with an accompanying person. Recalls about the colonoscopy procedure by calling 24 hours after the procedure; Undesirable effects such as nausea, vomiting, pain, dizziness, drowsiness and satisfaction with the procedure will be questioned.
Expectations and scientific contributions This research may help to understand the effects of giving or not administering intravenous fluids (restrictive/liberal) prior to the procedure in patients undergoing elective colonoscopy under sedoanalgesia. It can provide hemodynamic stability, reduction in drug doses, reduction of side effects, rapid recovery and discharge, and reduction of costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R (Restrictive) | Active comparator | Other: Colonoscopy, Other: SedoanalgesiaGroup R (Restrictive, 2ml/kg 0.9% NaCl during colonoscopy) |
| Group L (Liberal ) | Active comparator | Other: Colonoscopy, Other: SedoanalgesiaGroup L (Liberal 15ml/kg 0.9% NaCl during colonoscopy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signing the informed consent form
- Having irritable bowel disease, suspected colitis, unexplained iron deficiency and planning colonoscopy for screening
- Between the ages of 18-65
- According to the Physical Condition Classification of the American Society of Anesthesiologists, ASA I (a healthy person who does not cause normal systemic disorders, does not have a disease or systemic problem other than intestinal pathology) or ASA II (Person with mild systemic disorder due to a cause requiring intervention or another disease)
Key exclusion criteria (18 listed)
- Not signing the informed consent form
- Not between the ages of 18-65
- Having epileptic seizures
- The use of drugs that affect the nervous system
- Having a history of allergic reaction to study drugs
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 |
|---|---|---|
| ColonoscopyColonoscopy | Other | Group L (Liberal ), Group R (Restrictive) |
| SedoanalgesiaKetamine, fentanil, midazolam, propofol | Other | Group L (Liberal ), Group R (Restrictive) |
Primary outcome
Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia.
Time frame: During colonoscopy
Systolic blood pressure will be recoded.
Comparison of diastolic blood pressure in restrictive and liberal patients in colonosopy
Time frame: During colonoscopy
Diastolic blood pressure will be recoded.
Comparison of heart rate in restrictive and liberal patients in colonosopy
Time frame: During colonoscopy
Heart rate will be recoded.
Comparison of spO2 in restrictive and liberal patients in colonosopy
Time frame: During colonoscopy
spO2 will be recoded.
Comparison of procedure times in restrictive and liberal patients in colonosopy
Time frame: During colonoscopy
Procedure times will be recoded.
Comparison of total anaesthetic doses in restrictive and liberal patients in colonosopy
Time frame: During colonoscopy
Total anaesthetic doses will be recoded.
Comparison of nose and vomiting and other effects in restrictive and liberal patients in colonosopy
Time frame: 24 hours
Side effects will be recorded
Comparison of sedation levels in restrictive and liberal patients in colonosopy
Time frame: 24 hours
Ramsey and modified post anaesthetic discharge score level will be recorded.
2 secondary outcomes
Patient satisfaction
Time frame: 24 hours
Gastroenterologist satisfaction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 29101957Trummel JM, Chandrasekhara V, Kochman ML. Anesthesia for Colonoscopy and Lower Endoscopic Procedures. Anesthesiol Clin. 2017 Dec;35(4):679-686. doi: 10.1016/j.anclin.2017.08.007.
- Background: PubMed 25801162Tuncali B, Pekcan YO, Celebi A, Zeyneloglu P. Addition of low-dose ketamine to midazolam-fentanyl-propofol-based sedation for colonoscopy: a randomized, double-blind, controlled trial. J Clin Anesth. 2015 Jun;27(4):301-6. doi: 10.1016/j.jclinane.2015.03.017. Epub 2015 Mar 20.
- Background: PubMed 27108817das Neves JF, das Neves Araujo MM, de Paiva Araujo F, Ferreira CM, Duarte FB, Pace FH, Ornellas LC, Baron TH, Ferreira LE. Colonoscopy sedation: clinical trial comparing propofol and fentanyl with or without midazolam. Braz J Anesthesiol. 2016 May-Jun;66(3):231-6. doi: 10.1016/j.bjane.2014.09.014. Epub 2016 Mar 12.
- Background: PubMed 28045707Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.
- Background: PubMed 16733101Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE; American Society of Colon and Rectal Surgeons; American Society for Gastrointestinal Endoscopy; Society of American Gastrointestinal and Endoscopic Surgeons. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Gastrointest Endosc. 2006 Jun;63(7):894-909. doi: 10.1016/j.gie.2006.03.918. No abstract available.
- Background6. Indrakrishnan I and Varatharajah T. Management of Endoscopy Patients' Hydration Status during National Shortage of Intravenous Fluids. J Gastroenterol Liver Dis 2016; 1: 1001
- Background: PubMed 27194403Leslie K, Allen M, Lee A, Clarke P. A randomized-controlled trial of high- or low-volume intravenous Plasma-Lyte((R)) to prevent hypotension during sedation for colonoscopy. Can J Anaesth. 2016 Aug;63(8):952-61. doi: 10.1007/s12630-016-0672-4. Epub 2016 May 18.
- Background: PubMed 16802483Leslie K, Tay T, Neo E. Intravenous fluid to prevent hypotension in patients undergoing elective colonoscopy. Anaesth Intensive Care. 2006 Jun;34(3):316-21. doi: 10.1177/0310057X0603400314.
- Background: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Background: PubMed 8534468Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6. doi: 10.1016/0952-8180(95)00130-a.
- Individual participant dataSharing planned: No
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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.
Yonca Özvardar Pekcan principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy and Sedoanalgesia in people with Intravenous Infusions and Colonoscopy, run by Baskent University 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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonca Özvardar Pekcan (+902322411000 ext. 1085, yncapek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of systolic blood pressure in restrictive and liberal patients in colonosopy under sedoanalgesia. (time frame: During colonoscopy). The study lists 8 primary outcomes in all. 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 NCT05522127, which also lists 10 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 10 Mar 2023.